Total 14 it specialist job vacancies in Engineering category in The United States of America

Job Description

West Point Technical Operations is seeking a highly motivated Manufacturing Data Analyst to support data analytics-based projects across vaccine production areas at the West Point facility.   This role will blend the disciplines of engineering and data science to drive business value while fostering a culture of collaboration and innovation.

Position Description:

Digital Transformation is a key enabler to our Manufacturing Division's strategy and is rapidly gaining momentum.   There are numerous opportunities at the West Point manufacturing facility to provide business value utilizing digital and data tools.  Such opportunities include (but not limited to): predictive maintenance, process monitoring, process modeling, and tier dashboards.  In addition, increased support is needed for IT and global digital platforms that require site technical input.   These platforms include but are not limited to Aveva PI, DataIKU, Power BI and other data tools.  In this role, the Specialist will work as an individual contributor as well as a team member on various manufacturing data projects.  Additionally, this role will contribute to the performance of the site by providing technical guidance and anticipate and interpret client and/or customer needs to identify and implement solutions.

Additional Responsibilities:

• Builds digital/data solutions based on customer needs.  This may include use of coding languages (R or Python), data platforms (Amazon S3/Redshift, PI) and/or visualization tools (Spotfire, Qlik, Power BI etc.)

• Supports implementation of data driven solutions across the site.  Such solutions may come from various nodes of business at our company. 

• Works with stakeholders to define and apply best practices and/or standard work as it relates to data analytics or digital solutions.

• Serves as a site Data SME; offer technical advice/assistance when needed on various platforms and tools.

• Communication & collaboration with diverse stakeholders

• Promotes a culture of analytics and experimentation as a differentiator and competitive advantage – an environment that places high value on embedding analytical tools within business processes and using information to make fact-based decisions.

• May monitor the health of the processes through continuous monitoring, data analysis and modeling.  Communicates findings and recommendations to technical SMEs.

• May support complex manufacturing investigations and/or process improvement projects.

Required Qualifications:

• Minimum B.S. degree in Engineering or Sciences

• Minimum 1.5 years post-bachelor’s degree experience in manufacturing and/or technical support of manufacturing operations.

• Experience with digital or data solution development.

• Experience working with manufacturing data

• Strong collaboration and communication skills

Preferred Qualifications:

• Experience with statistical process control and/or Machine Learning and/or AI

• Experience working with Visualization platforms

• Experience in coding languages (R or Python preferred)

• Experience working with Aveva PI tools.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Description

The West Point, PA campus is our Company’s largest vaccine manufacturing facility with more than 2000 employees.  This facility manufactures bulk and/or final dosage forms for our Company's vaccine products and is growing to meet the vaccine demands of the future.

The Building B63A Vaccine Filling Facility Project team is seeking a highly motivated individual to fill an open position to support the start-up of a new vaccine filling & inspection facility at the West Point site.  Facility start-up will include design, commissioning, equipment qualification and vaccine drug product process demonstration in support of facility licensure.

The Specialist, Technical Operations is responsible for technical support for vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture.  In this role, the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Operations, Quality, Automation, and others. 

Additional responsibilities include:

• Support successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility

• Partner with cross functional team to develop process/procedures and complete successful qualification of equipment/process.

• Provide technical expertise for unit operation for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, qualification

• Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.

• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings

• Support process improvement projects and complex manufacturing investigations.

• Support digital and data integrity initiatives for the project.

• Provide technical support to manufacturing for complex problems and issues.

• Develop and assure consistent application of standardized work, engineering, and process tools.

• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

• Support regulatory submission preparation and inspections for the facility.

Qualifications:

Required:

• Bachelor’s degree in an Engineering or Science Related field

• Minimum 2 years of experience in GMP manufacturing and/or technical support of GMP manufacturing operations.

• Demonstrated a strong performance record and have excellent project management skills.

Preferred:

• Experience in biologics, vaccine or bulk sterile manufacturing facilities.

• Experience leading and managing departmental or cross-functional teams.

• Regulatory inspection presentation experience with external regulatory authority representatives

• Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies/certification

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Description

Preferred:

• Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management). Computerized Management Maintenance Systems SAP), and CMRP certification desired.

Note:  This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

 

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Description

Position Description:

Engineering - Senior Specialist, PA GWES Business Systems

The vision for the Global Workplace and Enterprise Services (GWES) organization based in Pennsylvania is to improve patient’s lives by providing world-class facility services & solutions that enable innovative research, medicines, & vaccines.  There are currently a growing number of strategic facilities initiatives required to support our Company’s existing and new product portfolio.  

The position is key to our exciting growth at the site and learning for the candidate.  The role is highly collaborative and will work closely with all operating areas to manage the capital and expense funding/execution of those facilities initiatives and drive our business insights digital strategy. 

Tasks include:

• Capital/Expense Planning and Management: Understand yearly capital/expense planning process; acts as liaison to the project execution teams of approved projects; ensures activities/initiatives align with current capital/expense allocations. Communicate updates to corporate capital and finance partners quarterly.

• Project Prioritization:  Facilitate prioritization discussion to rank potential projects. Ensure priorities are kept up to date with current objectives.

• Portfolio Management Program Reporting - Develop realization metrics, track realization, report realization, and ensure execution of project/program is delivering business realization goals.

• Business Insights:  Advance the data analytics strategy to monitor and improve business performance, ranging from VP to manager levels.    

• Operational Efficiency: Identify opportunities for operational improvements that can drive desired outcomes, increase efficiency, and enhance productivity. Implement measures to streamline processes, optimize resource allocation, and drive continuous improvement efforts.

Position Qualifications:

Education Minimum Requirement:

• BS Science or Engineering and relevant industrial experience

Required Experience and Skills:

• A minimum of 3 years of engineering/facilities work experience

• Analytical mindset, comfortable working with data and making data-driven decisions to achieve desired outcomes.

• Exceptional communication and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels.

• Team facilitation and leadership skills; able to establish cooperative team environments

• Enthusiasm for customer service.

Preferred Experience and Skills:

• Use of financial and portfolio management tools such as PowerBI, Qlik, etc.

• Lean Six Sigma certifications; e.g. Greenbelt

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey.

The Process Engineer role at the Senior Scientist level will support the Oral Solid Dosage Suite within the FLEx facility as a leader in the organization to help foster a culture of collaboration, learning and innovation. This role will support facility operations, formulation and process development activities, quality investigation and change management, author current good practices documentation and manage/lead scientists and contractors. 

The successful candidate will collaborate closely with the formulators, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of our Company's pipeline.

The candidate should also have pilot plant operations, and an affinity for hands-on problem solving on the shop floor.  A large part of the role will surround adapting equipment and facility capability to meet pipeline requirements through innovation, new technology and process improvements.  The role is based in New Jersey and reports to the Oral Solid Dosage Process Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply. 

Education Minimum Requirements: 

• PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 1 year or Postdoc or industry experience.

• M.S. degree with minimum of 4 years of relevant experience.

• B.Sc degree with a minimum of 7 years of relevant experience.

Required Experience and Skills:

• Knowledge of drug product processing.

• Ability to prepare Standard Operating Procedures (SOP) and current good practices (cGXP) documents.

• Effective interpersonal and communication skills, both verbal and written.

• Excellent organizational skills to handle multiple priorities.

• Desire and willingness to learn, contribute and lead.

• Track-record of independent problem-solving.

• Ability to work effectively with team-members of diverse skill sets and backgrounds.

Preferred Experience and Skills:

• Knowledge of investigational drug regulatory requirements.

• Experience with Commissioning, Qualification and Validation.

• Experience in leading and supporting quality investigations and change management.

• Experience with quality systems.

• Familiarity with U.S. and European Union GMP and Safety compliance regulations.

• Experience with SAP, ERP or MES systems.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

#EBRG

#vetjobs

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$111,400.00 - $175,300.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Description

This role is a Senior Specialist who would focus on our company's vaccine Drug Product Localization. The function of this position is to provide engineering technical support to the manufacture of liquid vaccine drug product at external partners as well as at our company's West Point. The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise.  Specific assignments may be focused in one area such as localization or span across multiple areas of focus based on the Technical Operations business needs and priorities.

The selected candidate will be responsible for:

• Serving as the main point of contact and SME for product franchise support of our company's vaccine Drug Product at external partners.  May require support of additional products or family of products.  The support can include but is not limited to tech transfer, validation, change controls, regulatory submissions, deviations and training of employees from external partners.

• Responsible for responding to questions from external partners.

• Collaborate effectively with the external partners and our company's External Manufacturing.

• With in depth product expertise, complete deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.  Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Authoring technical protocols, executing studies and reporting results/conclusions in support of product tech transfers, process improvement projects and deviation investigations.  The individual will be required to utilize sound engineering principles to support qualified validation processes as required per current Good Manufacturing Practices (cGMPs).

• Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process troubleshooting or to provide immediate responses to deviations and/or protocol exceptions.

• Collaborating effectively with the area Managers, Operators/Mechanics, support groups (Mechanical Services, Automation, Technical Operations), Quality, and Planning.

• Supporting team safety, environmental, and compliance objectives.

Other responsibilities that the candidate will get involved in as required:

• Supporting product Annual Review expectations including Continued Process Verification Reports, including pulling data, generating charts and statistically analyzing the data to identify whether preventative actions are required.

• Approving new or updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures).

• Performing validation assessments for proposed changes impacting the qualified processes.

• Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.

• Actively using and championing the use of Lean Six Sigma (LSS) tools, in problem solving and day-to-day operational activities

• Leading cross functional teams and acting as an individual contributor to drive change control and improvement projects across compliance, and strategic, including projects aimed at improving Right-First-Time performance, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times. 

• Authoring and approving Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes.  Managing on-time implementation and close-out to meet project, production and supply timelines.  

• Preparing source documentation for regulatory filings, supporting and serving as a lead SME during regulatory inspections related to process overviews, investigations, projects and validation.

Education Minimum Requirement:

• B.S. or equivalent in Science Related Field

Required Experience and Skills:

• Engineering or Science educational background

• Minimum of 5-years of post BS degree experience in vaccines in support of Production, Process Engineering, Technical Operations or related experience

• Hands-on experience in supporting formulation and aseptic filling including manufacturing scale filling isolators, RABS, or closed system processing

• Product franchise Tech Services experience

• Support deviation investigations

• Support project work

• Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

Preferred Experience and Skills:

• Experience with Trackwise, MEDS, SAP, MII, Delta V

• Experience with change control documentation and execution

• Participation in internal audits, regulatory inspections and/or interactions with regulatory agencies

• Experience with Clean-in-Place and Sterilize-in-Place systems

• Ability to read Piping and Instrumentation Diagrams is desired

• LSS certification experience

• Experience with Tech services support activities for introduction or launch of new product

Travel requirement of 25%

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Description

 

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

 

The Packaging Commercialization department has an exciting opportunity for a Specialist Packaging Engineer at either the Rahway, NJ or West Point, PA site. 

This candidate will serve as an individual contributor and foster our department mission to:

• Design and develop responsible and accessible commercial packaging solutions with strong science, risk-based thinking, and focus on the customer while

• Striking the balance of being innovative and flexible to meet the evolving pipeline, while also continuously improving and standardizing our packaging solutions. 

• Our Engineers have opportunities to collaborate across many diverse areas, including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation. 

 

Position Description:

The successful candidate will have the opportunity to focus on package development for a range of traditional pharmaceuticals (oral solid dosage, oral powders, suspensions, sterile injectables, and inhaled formulations) and biopharmaceutical applications (vaccines, monoclonal antibodies, and antibody drug conjugates) as well as provide input to primary packaging for the drug component and secondary packaging of medical device and combination products. Through support of the Packaging Working Groups, the successful candidate will collaborate with peers in drug product formulation and analytical development as well as supply chain and marketing to provide technical guidance during the development of primary, secondary and tertiary packaging for new products and specialty devices. 

 

Packaging Responsibilities:

• Providing input regarding selection of primary packaging material.

• Determination of package images to support commercialization as well as leading the shipping distribution strategy and coordination of shipping distribution studies efforts regarding testing robustness of packages. 

• The successful candidate will author packaging specifications for primary, secondary and tertiary packaging as well as provide information to support relevant sections of BLA’s, NDA’s, WMA’s, and JNDA’s. 

• The successful candidate will also interface with packaging component suppliers, our Company Global Packaging Technology Operations, our Company Packaging Site Operations, as well as Contract Manufacturing Operations while fulfilling their responsibilities.

 

Education Minimum Requirement:

• The successful candidate will have a completed a B.S. or higher degree in  Biomedical Engineering, Chemical Engineering, Materials Science, Packaging Engineering, Packaging Science, or Pharmaceutical Science

OR

• High School Diploma/GED with four (4) years of relevant experience in packaging or military service

 

Required Experience and Skills:

• Understanding of package development process and engineering principles

• Strong scientific- and risk-based thinking

• Demonstrated experience in building collaborative partnerships

• Excellent verbal and written communication skills

• Excellent  project management skills

• Ability to make rapid disciplined decisions

 

Preferred Experience and Skills:

• Packaging Engineering or Packaging Science degree with a minimum of one (1) year of relevant experience

• Experience in new product pharmaceutical and/or biopharmaceutical development packaging

 

Your role at our Company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our Company, we’re inventing for life. 

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

 

 

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$68,400.00 - $107,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

typical in process or finished bio-pharmaceutical materials

Job Description

Position Description:

Senior Specialist - Energy Engineering

The Energy Engineer provides technical support for project design and implementation and to optimize the operations and energy use of energy systems and equipment to achieve energy, emissions, and cost savings. The Energy Engineer works with building maintenance teams as well as utility operations team members to implement effective and innovative energy conservation measures for both supply and demand-side management strategies. The Energy Engineer also conducts energy assessments and site investigations, monitors and manages construction activities related to systems and equipment, interprets engineering documents, and drafts technical reports.

Responsibilities

• Works to implement effective and innovative energy conservation measures (ECMs) in both supply and demand-side management strategies in buildings and utility generation facilities.

• Provides engineering and technical support for project design and implementation and coordinates with  building maintenance and engineering teams to optimize the operations and energy use of energy systems and equipment.

• Analyzes systems and equipment to determine optimum operating conditions and diagnose issues impacting energy consumption; develops and recommends strategies to maximize operating efficiency.

• Reviews data from Energy Management and Information Systems (EMIS), such as the building automation system (BAS), and utility billing and meter data to identify opportunities for energy and operational savings.

• Performs technical energy audits and payback calculations.

• Researches, tests, and summarizes benefits of energy efficiency and renewable energy project concepts.

• Advises on equipment specifications, conducts bidding process with equipment suppliers for upgrades and energy retrofits, and supports annual energy budget preparation.

• Reviews capital project scope for compliance with company energy standards.

• Updates job knowledge by participating in educational opportunities, reading professional publications, maintaining professional networks, and participating in professional organizations.

Position Qualifications:

Education Minimum Requirement:

• Bachelor's degree in an applicable engineering field or other relevant degree from an appropriately accredited institution.

Required Experience and Skills:

• Minimum of five (5) years of experience or equivalent in relevant area.

• Demonstrated track record of delivering energy conservation measures.

• Knowledge of engineering practices and principles and experience in one or more of the following engineering fields: mechanical, electrical, environmental, civil.

• Experience with building systems and equipment, including implementing energy efficiency measures and optimizing equipment use.

• Experience interpreting engineering documents, evaluating construction plans, and using data to monitor and control mechanical systems.

• Ability to perform technical analysis.

• Ability to verbally communicate technical and nontechnical information to various stakeholders.

• Familiarity with ASHRAE standards.

• Ability to manage time independently and meet schedules and deadlines.

• Ability to identify high-impact energy conservation measures and manager energy efficiency projects.

• Professional certifications such as Certified Energy Manager (CEM) or Leadership in Energy and Environmental Design (LEED).

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

 

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

GWES

#eligibleforerp

gwesfinn400

vetjobs

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.

The Process Engineer role at the Specialist level will serve as a leader in the FLEx Oral Solid Dosage GMP Clinical Manufacturing facility.   This role will support formulation and process development, scale-up activities, quality investigations, change management and authoring GMP standard operating procedures and protocols in support of oral solid dosage clinical drug product operations. This individual will collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline. The role is based in New Jersey and reports to the Oral Solid Dosage Process Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply. 

Education Minimum Requirements: 

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 1 year relevant experience

• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field

Required Experience and Skills:

• Familiarity with United States and European Union GMP and Safety compliance regulations.

• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.

• Effective interpersonal and communication skills, both verbal and written.

• Excellent organizational skills to multi-task.

• Desire and willingness to learn, contribute and lead.

• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Experience or interest in supporting electronic batch records and MES systems.

• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.

• Experience in leading and supporting quality investigations and change management.

• Experience with Oral Solid Dosage GMP facility.

• Experience with Commissioning, Qualification and Validation.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

#EBRG

#VETjobs

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$80,320.00 - $126,500.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Description

The Sr. Specialist will be responsible for supporting the NJ Operations Master Plan and Portfolio. This position requires coordination and performance of multiple tasks, as well as a deep understanding of project principles, business strategies, and technical skills. The Sr. Specialist will collaborate with other business areas and divisions, engage with customers, and provide advanced analytical assessments, judgment, creativity, and problem-solving skills to complete various work assignments. They will also work internally and externally to develop industry best practices and standards. The Sr. Specialist will provide business and management expertise to translate business strategies into measurable objectives for teams, while leveraging relationships with key clients, customers, and organizational leadership to support business needs and achieve key objectives.

Responsibilities:

• Support the NJ Operations Master Plan and Portfolio.

• Coordinate and perform multiple tasks, demonstrating a strong understanding of project principles, business strategies, and technical skills.

• Review work priorities and activities with little supervision.

• Engage and collaborate with other business areas and divisions to achieve objectives.

• Produce and complete various work assignments, applying advanced analytical ability, independent judgment, creativity, and problem-solving skills.

• Collaborate with customers in operations, procurement, site tech ops, and global partner groups.

• Work internally and externally to develop industry best practices and standards.

• Manage the capital/profit planning process and capital/expense spending.

• Provide business and management expertise to translate business strategies into measurable objectives for teams.

• Leverage relationships with key clients, customers, and organizational leadership to support business needs and achieve key objectives.

Requirements:

• Bachelor’s degree BA/BS preferably in Science or Engineering

Preferred: 

• An advanced degree in Engineering, Project Management or Facilities Management

Skills and Experience:

• 5 or more years of engineering/scientific work experience

• Computer skills using MS Office Suite (Outlook, Word, Excel, Power Point etc.) and operation of other peripheral devices

• Understanding of finance and cash flow with respect to corporate purchasing:  SAP experience

     

Processing: 

• Purchase Orders and Payment Requests; Vendor Add Forms, as well as the capability to run reports within SAP 

• Previous experience with relational data bases and programming with a history of high performance

• Documented experience as a strong performer in current and past positions 

• Ability to handle and prioritize many simultaneous assignments

• Program management skills with an understanding of strategic vision and significant attention to detail

• Outstanding communication and people skills

• Ability to both think critically as well as communicate effectively with a global audience

• Experience with financial and budget tasks

• Technical problem-solving abilities.

• Fluent in English; bi-lingual in Spanish is desirable

Preferred:

• Must demonstrate excellent collaboration skills and enthusiasm for customer service.

• Experience in dealing with agencies and management of professionals outside of our company's required.   

• Lean, Six Sigma Black Belt/Green Belt certification or equal experience in application.

• Professional designations including Professional Engineering License, PMP, and Change Management preferred.

• Knowledge and experience in management of our company's projects and facilities. 

• Understanding of and experience with our company's capital and profit planning processes is required.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

 

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

GWES

#eligibleforerp

gwesfinn400

VETJOBS

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$101,100.00 - $159,100.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Job Description

Job Description:

This entry-level Associate Specialist Engineer position is within our Company’s Global Engineering Solutions (GES) organization, which is responsible for the design and construction of advanced manufacturing facilities and laboratories worldwide. We provide premier engineering solutions in the pharmaceutical industry through technical innovation and project management to deliver important life-saving medicines and vaccines to patients.

Our Company’s Manufacturing Division (MMD) and GES have a continued focus to build a high-performance organization by recruiting and developing talent through our highly coveted GES Development Program (GESDP).  This 3-year rotational program is an opportunity for high potential entry-level employees to experience and contribute meaningful impact to the design, build, and delivery of new and improved assets through engineering, technical innovation, and project management.

The GESDP consists of a combination of development assignments, leadership development, cross-functional learning, project work, coaching, and mentoring in a team-based environment to enable participants to work across divisions and geographies to increase their understanding of engineering and project management, build business and financial acumen, develop problem-solving and leadership skills.

Throughout your time in the program, we significantly invest in your development and prepare you for future opportunities. You are provided with day-to-day assignment managers, mentors, and "buddies." You will receive coaching from subject matter experts, face real-life design and engineering challenges from industry leading engineers, contribute to significant projects, and help make key decisions that directly impact how we design and construct assets to manufacture pharmaceuticals and deliver them to our patients globally.

Employees in the program complete several 4, 6, and 8-month rotations within GES over the course of three (3) years. Employees are onboarded at the start of the program and receive fit-for-purpose training prior to their first and before each subsequent rotation. Rotations are determined by business need in conjunction with employee interest and development opportunities. Rotations include but are not limited to:

• Business Integration and Project Design Management - work with the business to develop the project and managing/coordinate aspects of front-end engineering design.

• Our Company Production System – apply Lean methodologies to ensure facilities are built right-sized and fit-for-purpose.

• Estimating and Project Controls - learn the basics of developing budget estimates and controlling cost and schedule activities.

• Delivery – execute of a project from design phase to system handover to end user.

• Process Engineering - design, startup, commission, qualification, and operation for equipment and systems.

• Automation - design, startup, installation, and qualification of automated equipment and systems.

• Finance – oversee and maintain financial compliance posture between GES and external partners through ongoing monitoring and audits.

In addition to rotations, you are required to participate in additional GES-specific projects/initiatives and are encouraged also to participate in development opportunities to further build your knowledge, skillset, and network.

Upon completion of the program, successful participants are well-positioned to apply to targeted roles of interest and greater responsibility within GES to further develop and grow their career at our Company. Employees are equipped with strong foundational skills and have opportunities for significant networking and travel in supporting the capital projects across the company.

The primary site location for this position is Rahway, NJ. Additional assignment locations will be determined by the project needs at the time of the assignment and may include additional sites beyond the sites listed as part of this job posting.

Required Education and Experience:

• Candidates must be currently pursuing a bachelor’s or master’s degree in engineering (e.g., Chemical, Biomedical, Mechanical, etc.) or equivalent discipline from an accredited college/university with an anticipated graduation date by end of 2024 or 2025 to start full-time in 2025.

• Candidates must be eligible to work in the U.S. or lawful permanent resident of U.S. without sponsorship.

• Candidates must be willing to be assigned to different rotations and at different work sites over three (3) years in various aspects of the business based on business need.

Preferred Experience and Skills:

We are seeking prospective graduates with outstanding academic records of achievement and demonstrated leadership abilities, candidates who are analytical and inquisitive about the interrelationships of various components, and perceptive, quick learners committed to making a difference in the pursuit of manufacturing high-quality, market-leading pharmaceutical and vaccine products. Idea candidates:

• Possess superior written and oral communication and interpersonal skills.

• Are a team player with the ability to work independently.

• Have effective collaboration and problem-solving skills with a continuous improvement mindset and the desire to be innovative.

• Possess motivation, dependability, systems thinking, and active listening.

• Demonstrate leadership qualities.

• Possessing prior intern or co-op experience in a pharmaceutical manufacturing or engineering role and/or capital management experience is preferred.

MMD2024

FTP2024

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$68,400.00 - $107,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

Summary, Focus and Purpose

Under the supervision of a Senior Specialist or Associate Director, the Engineering EM&U Specialist is responsible for providing technical manufacturing support in the field of engineering, maintenance and utilities (EMU) and provides day-to-day engineering support for assigned area which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or mechanical support utilities including power, HVAC, steam, WFI and controlled temperature units.

You will support and monitor equipment performance and maintenance, propose and develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations and actively ensure GMP quality, safety, environmental, and operating cost goals are achieved. On occasion, may provide supervisory coverage to ensure supply of a quality product.

Key Functions

• Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations

• Champions the preventive and predictive maintenance program within your area of responsibility, reviews equipment history for reliability concerns, conducts root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs | Develops maintenance and repair strategy for bi-annual shutdowns

• Assists/Leads Operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction

• Serves as the project engineer and manager for small projects including scope development, design support, field execution and commissioning/qualification testing

• Identifies spare parts and stand-by equipment needed to assure maximum capacity and reliability

• Supports maintenance scheduling and planning processes in area of responsibility

• Supports positive safety culture and participates in HAZOP reviews and Safety inspections | Promotes open communications, inclusion and teamwork

• Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors

• Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan

• Explains and enforces all GMPs, safety, and environmental regulations

• Assist in audits, regulatory inspections and training in the area of responsibility

Education

• Bachelor of Science or Engineering degree or four year Engineering Technology degree

Required Experience and Skills

• Three years manufacturing experience or technical support group or equivalent

• Proficient in the following competencies: empowering leadership, flexibility, motivation, teamwork/collaboration, problem-solving, communication, and computer skills

• Knowledge in the application of engineering standards (i.e. ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI)

Preferred Experience and Skills

• Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management). Computerized Management Maintenance Systems SAP), and CMRP certification

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

Summary, Focus and Purpose:

Under the supervision of a Senior Specialist or Associate Director, the Engineering EM&U Specialist is responsible for providing technical manufacturing support in the field of engineering, maintenance and utilities (EMU) and provides day-to-day engineering support for assigned area which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or mechanical support utilities including power, HVAC, steam, WFI and controlled temperature units.

You will support and monitor equipment performance and maintenance, propose and develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations and actively ensure GMP quality, safety, environmental, and operating cost goals are achieved. On occasion, may provide supervisory coverage to ensure supply of a quality product.

Key Functions:

• Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations

• Champions the preventive and predictive maintenance program within your area of responsibility, reviews equipment history for reliability concerns, conducts root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs | Develops maintenance and repair strategy for bi-annual shutdowns

• Assists/Leads Operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction

• Serves as the project engineer and manager for small projects including scope development, design support, field execution and commissioning/qualification testing

• Identifies spare parts and stand-by equipment needed to assure maximum capacity and reliability

• Supports maintenance scheduling and planning processes in area of responsibility

• Supports positive safety culture and participates in HAZOP reviews and Safety inspections | Promotes open communications, inclusion and teamwork

• Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors

• Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan

• Explains and enforces all GMPs, safety, and environmental regulations

• Assist in audits, regulatory inspections and training in the area of responsibility

Education:

• Bachelor of Science or Engineering degree or four year Engineering Technology degree

Required Experience and Skills:

• Three years manufacturing experience or technical support group or equivalent

• Proficient in the following competencies: empowering leadership, flexibility, motivation, teamwork/collaboration, problem-solving, communication, and computer skills

• Knowledge in the application of engineering standards (i.e. ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI)

Preferred Experience and Skills:

• Experience with WFI/PS, HVAC/R, Compressed Air or other Utility systems

• Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management). Computerized Management Maintenance Systems SAP), and CMRP certification

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Description

Job Description

Our Manufacturing Operations teams are the people that make our products.  We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement.  We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, Intermediates and finished products. 

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Position Description

This position is a key member of the External Manufacturing & Network Equipment team that will be responsible for leading product/technology transfers to Contract Manufacturing Organizations (CMO) and to serve as a key technical interface liaison with our Company internal packaging sites in the areas of packaging equipment design/development, packaging process and controls and packaging operation.

Under general scientific and administrative direction, the engineer leverages experience gained on scientific, technical, and business issues, to lead project teams and technical staff to solve complex packaging problems. The engineer will demonstrate knowledge, skills and abilities to optimize business, technical, and compliance processes.  The person in this position participates in high impact, complex cross-functional and cross-divisional teams and initiatives and provides leadership to achieve project goals.  Effective collaboration with teams is essential to meet our Company's goals/objectives.  The ability to apply these skills in a fast-paced technical operations environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. 

Some key areas of responsibility include:

• As part of the ExM & Network Equipment team, establishing a calibrated technical oversight approach based on the product type, as well as the capabilities and technical competence of an external partner;

• Technology & Product Transfers, Qualifications, Validations, Process Improvements, and Change Control;

• Assurance of compliant packaging process execution and project management;

• Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining to the external packaging partners;

• Technical aspects of fact finding around quality and supply investigations, including leading root cause analyses, and developing robust preventive actions;

• Significant experience with packaging operations support, packaging development, packaging materials, packaging equipment and packaging processes;

• Supporting technical due diligence assessments;

• Assuring technical site readiness for all new product introductions or technology transfers;

• Participating in periodic Business Review Meetings with external packaging partners;

• Leading complex changes of packaging images and primary, secondary, and tertiary materials;

• Qualification of changes to distribution and thermal transport/storage systems and methods for finished drug products;

• Qualification of functional aspects of container closure systems, such as Child Resistance.

Education Minimum Requirement:

• BS degree in Packaging Science, Mechanical Engineering, Chemical Engineering, Materials Science, or similar

Required Experience and Skills:

• 7+ years of experience working in medical device, pharmaceutical or in biotech organization with hands-on experience with packaging operations support, packaging materials/components, and packaging processes.

• Knowledgeable of design control, medical device, combination products, pharmaceutical packaging and related scientific/technical concepts and techniques are highly desirable.

• Desirable to have prior experiences working inside a pharmaceutical packaging facility or in an External Manufacturing technical role.

• Highly proficiency in project management skills, from conception and initiation, through close-out.

• Has a mastery of packaging scientific/technical concepts and techniques, applies and furthers those concepts and techniques to execute in pursuit of resolving scientific/technical packaging issues.

• Significant experience with medical device or combination product transfer, operations support, and materials/components.

• Experience using quantitative decision tools for Risk Management and options analysis.

• Completes activities with the highest regard for all Company divisional and local site procedures for safety, quality, and regulatory compliance.

• Excellent oral and written communication skills

• Proven ability to provide technical leadership and apply technical skills in a fast-paced, complex environment.

• In depth understanding and proven expertise in application of GMP’s, quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification.

• General understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex task.

• Strong analytical and decision-making skills.

• Demonstrates Leadership Behaviors and Inclusive Behaviors.

Preferred Experience and Skills:

• Proven project leadership/ management and complex problem-solving skills.

• Ability to determine areas of potential risk to business success and generate gap analysis.

• Significant experience with packaging operations support, packaging development, packaging materials, packaging equipment and packaging processes. Significant experience with current Good Manufacturing Practices, Pharmaceutical industry regulations, packaging equipment system life cycle and project management.

• Strong oral and written communication skills.

• Experience with key manufacturing change control compliance systems such as Veeva and/or other similar systems.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

 

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$101,100.00 - $159,100.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.  For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a