Total 6 it specialist job vacancies in The United States of America

Key Responsibilities

End User Operation Support

• Acts as Point of Contact for End User/business stakeholders in terms of business requests and IT related issues via IT service ticket system.
• Perform Level 1 On Site/Remote support and troubleshoot to applications not limited to the following applications/system such as ERP System (SAP S/4HANA, EWM, Plant Maintenance, etc)), LIMs, MES etc
• Escalate and follow through IT Service tickets to Remote Core teams such as Level 2 Support Teams or DevOps Teams to resolve issues in a timely manner.
• Assign the correct and reasonable priority for IT issues on request of the end user
• Triages, prioritizes requests and tries to identify the nature / root cause of an issue (handling issue, data issue, authorization issue, IT issue).
• Distributes application issues that cannot be solved by him/her to the Level 2 Teams.
• Supports issue clarification on request of the Level 2 Support Teams.
• Validate the resolution proposals and perform the necessary test in case tests are required on request of the Level 2 Teams.
• Cooperate with Level 2 Support Teams during analysis of reported incidents
• Maintain close coordination and communication with End User/site business stakeholders for major incidents.
• For new IT initiatives/product/system roll out/Go Live to site, provide on site/remote on call support per business requirement such as adopting business shift pattern during initial roll out and stand down to remote On Call post Hyper Care after successful roll out.
• Support Global/Enterprise and Local ITOT application/system.
• Support application/system lifecycle such as OS or application release and upgrade, security patching etc for local ITOT systems if required.
• Act as Subject Matter Expert on IT technical related type of requests and enquiries to support business during GMP audits; Planned/Unplanned Events etc.
• Provide 24x7 routine operation service support per Service Level Agreements to business.
• Support/Participate Lifecycle planning/execution of ITOT systems (if applicable/required)
• Describes the full lifecycle of an integrated Change process to Business Process or IT System or both. This Framework combines the Assessment of the requirement, Build and Test work as well as Deployment and eventually delivery of the added value to the End User.
• Support/Participate Computer System Validation qualification for ITOT system (if applicable/required)
• Support/Participate retirement/decommissioning ITOT system/applications (if applicable/required)
• Adhere to the requirements specified in IT related Roche's quality policies/quality standards or related SOP.

Continuous Improvement

• Support/Lead Continuous Improvement opportunities related to ITOT applications/system.
• Regular exchange with the Support network and or BPMs on support cases, best practices and process improvement proposals with network relevance
• Helps the End User to submit new ideas for process improvements, allowing a comprehensive approach for assessing both the process interdependencies as well impact to all underlying systems.

Onboarding & Training

• Coordinate and conduct End User training
• Supports user authorization workflows (e.g. request, verify training, approve)
• Add information to the knowledge base
• Create/Review information Knowledge Article
• Create/Review training material
• Initiate knowledge management process

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Qualifications

Education/Certification/Working experience

• BS or higher degree in Chemical Engineering, Electrical Engineering, Computer Science/Engineering, business administration or equivalent degree with at least 3 years relevant work experience in the pharmaceutical industry
• Experience/familiar with IT/Automation system support in biotech/pharmaceutical manufacturing GMP environment is a plus
• Experience with the design, implementation, commissioning, qualification/validation and maintenance of Manufacturing Execution Systems (MES), and/or Process Automation Systems (PAS). Experience or familiarity with Emerson Syncade MES, SAP S4 HANA, Mulesoft, SingLIMs is a plus.
• Knowledgeable about Windows Server Administration, SQL Databases, OPC communication, crystal report, software development for web based interface, integration with enterprise business systems (Mulesoft, LIMS, SAP, etc), TCP/IP, Cyber Security and Data Integrity concepts.

Soft Skills

• Strong technical writing, verbal communication, interpersonal and problem-solving skills
• Strong analytical skills for effective troubleshooting and problem solving
• Candidates must be able to work well with others as a team member in an informal results- oriented work environment.
• Self-driven, Must have good communication skills (both verbal and written), and be able to work collaboratively with other groups.
• Passionate in learning and sharing/leveraging best practice; embed it as “next practice” to achieve greater impact
• Good service delivery through agile mindset, stability , flexibility and speed
• Eager to explore new technology and have the ability to learn new concepts.
• Excellent Customer Service/Interpersonal skills

1) General

a. Department: Quality

b. Reports to: MQA Team Leader

2) Purpose

● Provide QA oversight for RSTO to ensure that investigational medicinal products (IMPs) and commercial medicinal products are manufactured in accordance with global Roche, Pharmaceutical Quality System (PQS) and local site requirements.

● Responsible for escalation of quality issues following the criteria defined in current governing documents

● Support and/or perform routine “Make, Assess, Release” operations to meet targets and timelines

● Participate in the design and implementation of department and cross-functional initiatives

● To undertake additional responsibilities as required by Quality Management to meet business needs.

3) Key Responsibilities

Technical and Functional:

● Perform batch record, batch reports, logbook, cGMP documents and audit trail review to ensure quality of product, compliance to Roche requirements and on-time batch disposition per defined adherence to lead time

● Perform the following activities with QA oversight in accordance with Health Authority, Roche site and global PQS requirements:

- Provide guidance on categorization of unplanned events

- GMP area, Utilities and equipment release

- Execute Periodic Floor Walk

- Review Environmental Monitoring and Clean Utility Trend Control Strategies

- RSTO site Environmental Monitoring, Clean Utility Trend and Pest Control Reports approval

- Annual Audit of QC Controlled Print Documents

● Perform assigned tasks and manage competing priorities while meeting timelines to achieve company goals and department objectives

● Perform Change control assessment

● Perform Like to Like Assessments

● Notify Senior Management of potential quality, regulatory and compliance issues

● Support regulatory inspections and partner audits

● Serve as lead for Quality initiated programs

● Serve as trainer for core role specific activities

- Prepare training materials and conduct training on MQA-related procedures and processes as required

● Work alongside MQA Supervisor/ Manager in the following manner:

- Foster positive team environment by being inclusive while appreciating individualism

- Represent MQA in cross-functional meetings and discussions

- Serve as MQA subject matter expert (SME) during HA audits

Safety, Health & Environment:

· Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.

· Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

· Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

4) Qualifications

· Degree in Life Sciences or Engineering discipline or equivalent

· 1 to 5 years of related working experience for degree holders or equivalent holders with combination of education and relative work experience

· Related working experience in a biotech or pharmaceutical operating environment is preferred

· Good knowledge of quality systems and QA principles, practices and standards for the pharmaceutical industry

· Strong knowledge of cGMP and GDP relevant to the pharmaceutical industry

· Able to make sound decisions on quality matters

· Demonstrated excellent organizational and planning skills in managing priorities

· Meticulous, systematic and of an analytical mind

· Good interpersonal, oral and written communication skill

· Proactive team player

· Proven ability to work well under pressure

· Flexible in work hours (including shift work) to meet business objectives

The Career Conversion Programme (CCP) (Train-and-Place) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand. This programme is jointly supported by the Workforce Singapore (WSG) and Workforce Advancement Federation (WAF). The training programme consists of 15 months of local attachment with Roche.

Who are we looking for?

• Fresh Graduates who have recently graduated, OR;
• Candidates with 2 years working experience and above. Not in a similar job function prior to joining this TnP Programme.

Job Overview:

• Perform routine and ad-hoc environmental monitoring (EM) of critical utilities such as HVAC/BSC/VLFH/HLFH, water systems, compressed air/gas system and personnel monitoring
• Lab testing of EM samples in accordance with cGMP regulations and Roche/Genentech standards.
• Support manufacturing operations by timely completion of testing and disposition.

Key Responsibilities:

Technical and Functional:

• Perform EM which includes HVAC/BSC/VLFH/HLFH monitoring, compressed gas, personnel monitoring, water and clean steam sampling in accordance to cGMP procedures.
• Perform testing and review of routine and non-routine environmental monitoring samples in accordance to the Standard Operating Procedures (SOP).
• Documentation and review of results in the Laboratory Information Management System (LIMS) and/or documents in accordance with cGMP Procedures.
• Prepare EM trend graph periodically for trend data analysis.
• Operate laboratory autoclave and EM testing equipment.
• General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab supplies, etc.
• Perform daily checks in EM LIMS to ensure all assigned EM tasks are completed and/or tested on time.
• Initiate discrepancy record for EM action excursion, adverse trend and/or discrepant event.
• Carry out assignments / projects given by Supervisor. Deliver results per plans / schedules.
• Communicate all problems / issues timely to Supervisor.
• Suggest improvements to streamline / facilitate workflows.
• Participate in internal / external audits and regulatory inspections.
• Responsible for ensuring that all training required to support / perform GMP activities are completed timely.
• Monitor and keep track of inventory stocks for laboratory consumables and items required.
• Perform sample receipt and storage of QC samples.

Leadership:

• Work co-operatively with the Head of Micro/EM and QC Supervisor to create an environment of strong team spirit, timely and effective communications. Strive towards team’s objectives / goals, takes the initiative and proactively turn ideas into action – to make things happen.
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
• Embody PT behaviors, lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.
• A team player and the willingness to cover other colleagues in continued support of the Micro / EM operations.

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Key Interfaces:

• Other QC functions
• FEES / Utilities
• Manufacturing
• Warehouse
• Safety, Health and Environmental (SHE)

Qualifications:

Education

• Bachelor’s degree in a relevant science field or equivalent

Knowledge / Skills / Competencies:

• Demonstrate good verbal and written communication skills in English
• Independent, reliable and collaborative team player
• Able to follow written procedures.

Prepared to work overtime on weekday(s), weekend and/or Public Holiday and willing to perform shift duty if required

Job Description & Requirements

Purpose

The OE Specialist is responsible for the successful deployment and sustainment of Lean Production System (LPS) and oversees Business Process Management. He/She will collaborate with functional stakeholders to implement LPS, build Operational Excellence capability (such as Lean Six Sigma, Data Analytic, Problem Solving and Process Improvement), and lead focused improvement projects and initiatives.

As a strong Operational Excellence advocate, the OE Specialist serves as change agent to strengthen the CI culture and practices across the site. This includes developing and implement continuous improvement activities and programs, coaching and mentoring staff at different levels, and take on the role of resident expert in OE knowledge, methods and practices.

One of the key success measure of this role is helping the site achieve year-on-year productivity improvements through driving waste reduction, efficient operation and establish robust processes.

Key Responsibilities

LPS Deployment and Sustainment

• Supports LPS deployment and maturity.
• Facilitates annual site goals and objectives cascade to DR&S, functional and individual goals using LPS (such as Hoshin Kanri) and OBP.
• Drives business process management and practices to ensure operational stability and consistency.
• Develop and implement communication, change programs, community of practices (CoP) to foster and strengthen continuous improvement (CI) culture.
• Conducts training in OE methodologies, coach and mentor individuals and teams in applications towards skill mastery.

Productivity Improvement

• Leadership of focused improvement and optimization projects and initiaitives
• Collaborate with functional stakeholders to identify improvement opportunities using Lean tool (such as VSM, Loss analysis) and Six Sigma tool (such as SIPOC, FMEA, DOE, Data analytics).
• Supports all site functions/areas in problem solving and continuous improvement.
• Keep abreast with current OE methodologies (internal / External) and bring in best practices, innovative and improvement ideas.
• Manage and monitor site productivity plan to ensure healthy pipeline of improvement projects, good progress, and benefits realization.

Purpose

The OE Specialist is responsible for the successful deployment and sustainment of Lean Production System (LPS) and oversees Business Process Management. He/She will collaborate with functional stakeholders to implement LPS, build Operational Excellence capability (such as Lean Six Sigma, Data Analytic, Problem Solving and Process Improvement), and lead focused improvement projects and initiatives.

As a strong Operational Excellence advocate, the OE Specialist serves as change agent to strengthen the CI culture and practices across the site. This includes developing and implement continuous improvement activities and programs, coaching and mentoring staff at different levels, and take on the role of resident expert in OE knowledge, methods and practices.

One of the key success measure of this role is helping the site achieve year-on-year productivity improvements through driving waste reduction, efficient operation and establish robust processes.

Key Responsibilities

LPS Deployment and Sustainment

• Supports LPS deployment and maturity.
• Facilitates annual site goals and objectives cascade to DR&S, functional and individual goals using LPS (such as Hoshin Kanri) and OBP.
• Drives business process management and practices to ensure operational stability and consistency.
• Develop and implement communication, change programs, community of practices (CoP) to foster and strengthen continuous improvement (CI) culture.
• Conducts training in OE methodologies, coach and mentor individuals and teams in applications towards skill mastery.

Productivity Improvement

• Leadership of focused improvement and optimization projects and initiaitives
• Collaborate with functional stakeholders to identify improvement opportunities using Lean tool (such as VSM, Loss analysis) and Six Sigma tool (such as SIPOC, FMEA, DOE, Data analytics).
• Supports all site functions/areas in problem solving and continuous improvement.
• Keep abreast with current OE methodologies (internal / External) and bring in best practices, innovative and improvement ideas.
• Manage and monitor site productivity plan to ensure healthy pipeline of improvement projects, good progress, and benefits realization.

Purpose

The OE Specialist is responsible for the successful deployment and sustainment of Lean Production System (LPS) and oversees Business Process Management. He/She will collaborate with functional stakeholders to implement LPS, build Operational Excellence capability (such as Lean Six Sigma, Data Analytic, Problem Solving and Process Improvement), and lead focused improvement projects and initiatives.

As a strong Operational Excellence advocate, the OE Specialist serves as change agent to strengthen the CI culture and practices across the site. This includes developing and implement continuous improvement activities and programs, coaching and mentoring staff at different levels, and take on the role of resident expert in OE knowledge, methods and practices.

One of the key success measure of this role is helping the site achieve year-on-year productivity improvements through driving waste reduction, efficient operation and establish robust processes.

Key Responsibilities

LPS Deployment and Sustainment

• Supports LPS deployment and maturity.
• Facilitates annual site goals and objectives cascade to DR&S, functional and individual goals using LPS (such as Hoshin Kanri) and OBP.
• Drives business process management and practices to ensure operational stability and consistency.
• Develop and implement communication, change programs, community of practices (CoP) to foster and strengthen continuous improvement (CI) culture.
• Conducts training in OE methodologies, coach and mentor individuals and teams in applications towards skill mastery.

Productivity Improvement

• Leadership of focused improvement and optimization projects and initiaitives
• Collaborate with functional stakeholders to identify improvement opportunities using Lean tool (such as VSM, Loss analysis) and Six Sigma tool (such as SIPOC, FMEA, DOE, Data analytics).
• Supports all site functions/areas in problem solving and continuous improvement.
• Keep abreast with current OE methodologies (internal / External) and bring in best practices, innovative and improvement ideas.
• Manage and monitor site productivity plan to ensure healthy pipeline of improvement projects, good progress, and benefits realization.