Total 56 job vacancies by U341 Alcon Research, LLC. Company

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate ambitiously, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your dedication and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, hardworking people to join Alcon! As a Manufacturing Associate supporting our manufacturing site, you will be trusted to work alongside Production Technicians and Electro-Mechanics to help maintain production at Johns Creek, GA.

In this role, a typical day will include:

• Constructing, solving problems, calibrating, adjusting, testing, diagnosing, and maintaining, equipment, components, devices, or systems

• Working from schematics, engineering drawings, and written or verbal instructions

• Operating related equipment; conducting tests and reporting data in the prescribed format

• Performing calibration and alignment checks

• Making adjustments, modifications, and replacements as advised

• Preparing prescribed compounds and solutions

WHAT YOU’LL BRING TO ALCON:

• High School Diploma or Equivalent

• The ability to fluently read, write, understand and communicate in English

• MA Assessment is required for internal candidates only before hire if no technical degree or certification has been acquired

• Work hours: 36 - 48 hours per week (12-hour rotating day shift: 2 nights on, 2 nights off, and every other weekend)

• Travel Requirements: 0%

• Sponsorship & Relocation Not Available

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:

• Associate Degree in Engineering/Science/IT or Technical Certification

• Prior manufacturing experience is a plus

HOW TO THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a MS&T PRODUCT STEWARD, supporting our MANUFACTURING SCIENCE & TECHNOLOGY TEAM , you will be trusted with owning the process knowledge of the products assigned throughout the commercial lifecycle, maintaining oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring processes are robust, in continued state of validation and continuously improving and in compliance with cGMPs, SOPs, and applicable guidelines and normatives at the ASPEX FORT WORTH MANUFACTURING FACILITY in FORT WORTH, TEXAS, US.  

In this role, a typical day will include:

• Process/Product Oversight and Knowledge: Maintain the oversight of the process of the product(s) assigned “door to door” at the site.

• Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle, from inception to date.

• Primary contact with R&D as the plant Sustaining Scientist.

• Oversee implementation of systems, policies and procedures to ensure that products and services meet regulatory and quality standards.

• Monitor processes, identify problems and initiate appropriate corrective actions, including deployment of available resources.

• Monitor, analyze and recommend/implement improvements to better utilize labor, raw materials and equipment.

• Manage significant projects.

• Determine and communicate priorities and schedules between potentially conflicting areas.

• Monitor, analyze, and control variables.

• Maintain awareness of state-of-the-art equipment and processes; recommend and implement changes, as applicable.

• Prepare analyses and provide input to Site Management for use in strategy setting.

• Critically review operations for ways to improve regulatory compliance, aseptic techniques, product quality and/or productivity.

• Track, evaluate and report on key indicators, as well as corrective and preventive actions.

• Investigations/Improvement on Product: Initiate and support investigations and improvement projects involving cross functional teams based on data analysis.

• Actively participate and represent assigned products to the relevant governance where improvements on weak point products are planned, prioritized and monitored.

• Provide oversight and support of the Continued Process Verification (CPV) program.

• Change Control: Participate and/or lead (case by case) the change control of assigned products and related processes.

• APQR: Review the PQR data and provide the correct level of discussion on it.

• Training: Own the Training Curriculum for assigned Job Profile and provide training and support to new associates joining related functions.

• Audit Support: Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.

• Provide a safe working environment that complies with applicable standards, and that associates are working safely.

• Continuously monitor work areas; identify, resolve, and report safety hazards.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0yrs)

• The ability to fluently read, write, understand and communicate in English

• 5 Years of Relevant Experience

• Work hours: Monday through Friday – 8:00am – 5:00pm

• Travel Requirements: 0 to 10%

• Relocation assistance: No

• Sponsorship available: No

PREFERRED QUALIFICATIONS:

• Bachelor’s Degree in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific or engineering degree

• 6 or more years of relevant experience in pharmaceutical manufacturing

• Proven process understanding of Pharma, GMP, Regulatory aspects

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolve

• See your career like never before with focused growth and development opportunities

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates; PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As an ELECTRO-MECHANICAL TECHNICIAN supporting our MAINTENANCE TEAM you will be responsible for REPAIRS, ADJUSTMENTS, AND ONGOING MAINTENANCE OF THE FACILITIES AT FORT WORTH ASPEX MANUFACTURING IN FORT WORTH, TEXAS, US,

In this role, a typical day will include:

• Troubleshoot line/equipment mechanical and electrical problems, and perform efficient corrective maintenance to bring line/equipment back into a running and reliable state.

• Write and implement SOPs and Preventive Maintenance (PM) procedures.

• Identify and implement mechanical/electrical changes to enhance quality, compliance, reliability and reduce cost, following cGMP and SOPs, with minimal supervision.

• Work with Production to determine line/equipment reliability issues; provide regular feedback on line/equipment status and estimated time to repair.

• Safely use maintenance hand/power tools and test equipment.

• Technical: Troubleshoot and maintain equipment to fill and package products in accordance with standards and procedures (cGMP, SOPs, etc.).

• Perform technical setup of line/equipment for daily operation, according to SOP for assigned work area.

• Maintain aseptic personnel certification, and practice good aseptic techniques in performance of duties.

• Assist plant engineers in new equipment startups and engineering changes.

• Support training of new coworkers, and share knowledge and experience with coworkers to develop team’s overall capability.

WHAT YOU'LL BRING TO ALCON:

• High School Diploma or equivalent 

• The ability to fluently read, write, understand and communicate in English 

• 4 Years of Relevant Experience 

• Work hours:  6pm to 6am, 4 days on shift/4 days off shift

• Travel Requirements: 0 to 10%

• Relocation assistance: No

• Sponsorship available: No

PREFERRED EXPERIENCE:

• Industrial maintenance / trouble shooting

• Manufacturing Electro-mechanic experience

• Abilities on electrical, electronic, pneumatic and mechanics

• Experience repairing different types of machinery

• Basic Troubleshooting - breakdown steps to trouble shoot errors

• Manufacturing automation equipment -high volume / high speed equipment

• General automation knowledge, PLCs, photo eyes, VFDs, etc.

• Filling and carton experience. 

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolve

• See your career like never before with focused growth and development opportunities

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates; PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

Accountabilities:

•    Perform daily functions in the lens processing pilot line including basic knowledge of molding, fill/close, curing, de-molding, hydration, extraction and inspection in compliant and efficient manner.
•    Perform manufacturing batch record review.
•    Carry out essential tasks of Pilot Line Technician as required maintaining production schedule adherence and efficiencies. These essential tasks include: Monomer and solution prep manufacture; Set up and running of Dry molding lines, Metrology testing in the Dry area, Operation of the Fill and close Module, Operation of the curing process, Process lens molds through the demolding/delensing process, Prepare and set up the hydration tanks and follow lenses through the hydration and extraction process, Perform lens inspections per procedure and training certification, Perform Final QC testing, Perform Lens Sectioning.
•    Provide basic maintenance to lens manufacturing equipment.
•    Complete all necessary inventories and documentation for lens processing.
•    Responsible for inventory of the number of lenses processed.
•    Complete all documentation following the lenses throughout the manufacturing process.
•    Prepare select lenses for clinical trials.
•    Verify lenses are manufactured according to documented procedures.
•    Complete all necessary documentation to support both clinical and non-clinical pilot production
•    Assist with any additional projects assigned by Cross functional teams.
•    Foster a culture of inclusion, efficiency and compliance within the Pilot Line Team.
•    Ensure all necessary inventories and documentation for lens processing is complete.
•    Ensure all forms kept In the Pilot Line Lab used to track performance of required periodic cleaning, calibration, etc., are current and compliant.

Knowledge, Skills and Abilities:

·         Working knowledge in MS Office Suite, including Word and Excel.

·         Must be detail oriented and have excellent hand-eye coordination.

·         Working knowledge of cGMP requirements.

·         Must be willing to “Lead by Example”.

·         Effective teamwork and communication skills.

·         Ability to meet strict deadlines and work under pressure.

·         Flexibility in accepting work assignments as required by the needs of the business.

·         Medical Device or related regulatory industry experience is preferred.

·         cGMP experience is required.

·         R&D pilot operations experience is preferred.

Work Environment:

·         The individual will be required to work in Laboratory Controlled environment, working with and around machinery. Possible extended periods of sitting, inspecting parts through Opticspec, working with chemicals and processing equipment, as required.

·         Flexibility in working hours is required e.g. to meet deadlines i.e. working early/late/outside of normal hours.

·         The role will require the individual to come into contact with hazardous materials or working environments. The individual will be required to wear/use the appropriate personal protective equipment (PPE) for the task in hand outlined in SOP’s including items such as lab coat, eye protection and gloves. The job requires the handling of materials that come under HSE guidelines.

Minimum Requirements:

• High School Diploma or Equivalent

• The ability to fluently read, write, understand and communicate in English

• Work Hours: 40 Hours a week

• Relocation Assistance: No

• Sponsorship Available: No

• Travel Requirements: No Travel Required

#LI-DNI

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. Join our team to help people #SeeBrilliantly!

Responsibilities:

• As corporate SME interprets regulatory standards or guidance relating to reprocessing and translates into local and corporate procedures.

• Establishes global implementation strategy and timelines for new or updated standards.

• Provides detailed analysis of standards and impact on existing technical files.  Partners with sustaining engineers to properly maintain reusable product technical files.

• Proactively monitors literature, standards, industry guidance, trends, and customer reprocessing expectations globally.

• Rapidly assimilates new technology and requirements, evaluates long term organizational needs in reprocessing.

• Monitors and represents Alcon globally on select reprocessing standards committees.

• Collaborates with Marketing, CASs, and HFE's to optimize reprocessing for customers and create global competitive advantage.

• Guides NPI teams globally in developing suitable reprocessing methods, instructions, and requirements.

• Guides engineers during product lifecycle activities relating to reprocessing requirements.

• Provides guidance to reprocessing label development or updates to meet evolving regulatory and customer requirements.

• Provide SME input during regulatory or corporate audits, and regulatory submissions.

• Collaborates with RA/QA and Med Info Teams to develop materials to address customer inquiries.

• Provides SME input for inquiries from customers, regulators, or Alcon staff relating to execution, content, and alternatives to reprocessing instructions.

Major Accountabilities

• Performs corporate level assessments of emerging, newly published, or recently altered standards impacting the reprocessing field.

• Leads critique/evaluation of product design and directions for use with respect to reprocessing objectives. 

• Provides expert technical guidance, maintains local and corporate reprocessing procedures, directs/conducts reprocessing verifications. 

• Works with teams to address reprocessing challenges, design reprocessing methods, and validate methods to support project objectives.

• Develops superior cleaning, disinfection, drying, and sterilization test methods as needed to advance state of the art practices and customer needs.

• Provides QA/RA with summaries or guidance in regulatory submissions, audits, or preparing IFUs.

• Develops in-depth understanding of configuration, application, and engineering of reusable devices, establishes product families and adoption practices.

• Leads efforts to select/approve external labs as strategic partners in developing better reprocessing regimens; develops in house test methods as feasible.

• Collaborates with PSE to ensure technical files are updated as needed to stay compliant to current standards.

• Lead efforts to address customer inquiries, develop FAQ resources with RA/QA or Global Med Info groups.

• Create (or oversee) protocols, coordinate testing, verification reports, needed to support reprocessing instructions.  Identify when reverification is required.

Experience:

10+ years of experience in QSR/EU MDR compliant medical device development including ability to:

• Provide global technical leadership.  Influences effectively in a cross-functional environment (e.g. multi-site, NPI, customer inquiry support)

• Provide SME interpretation of: ISO 11135, ISO 11138-X, ISO 10993-X, ISO 17664-1/-2, ISO 17665-X, ISO 11607-X, ISO 15883-X, EN 13060, EN 285, AAMI ST 79, AAMI TIR 12/30, AAMI ST8, AAMI ST98, ISO 14161, EN 14885, EN ISO 11737-X, FDA Endotoxin and Reprocessing guidelines, RKI Guidance, MHP Central Sterilization supplements.

• Effectively communicate complex concepts in presentations, regulatory submissions, and in technical reports to global audiences.

• Develop reprocessing methods, lead IFU validations, resolve cleaning and sterilization concerns during development.

• Apply detailed knowledge of common microbiological and biochemical laboratory methods (sterility & disinfection testing, protein/TOC/endotoxin assays, etc.)

Key Requirements/Minimum Qualifications:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs) 

• The ability to fluently read, write, understand, and communicate in English.

• 7 Years of Relevant Experience 

• Work hours: M-F, standard

• Travel Requirements: 10%

• Relocation assistance: yes

• Sponsorship available: yes

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ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Total Rewards

Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value.  The first layer of our rewards program is compensation.  We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population.  Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.  To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click here

Pay Range

Pay Frequency

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Sr. Validation Engineer supporting Manufacturing Science & Technology, you will be trusted to work on design, develop, and implement new or revised production processes for the efficient/economical mass production of goods at Sinking Spring, PA.

In this role, a typical day will include:

• Use principles based on validation and risk management tools (e.g. FMEA) to lead in the development and maintenance of Validation Master Plan(s)/Validation document(s)for process, systems, cleaning, and packaging.
• Maintain the validation program for the manufacturing site in liaison with corporate/industry standards.
• Establish and maintain an overview of the state of validation for assigned projects and product platforms and assist in establishing the project prioritization including leading resources for validation efforts.
• Be responsible for the translation of critical quality attributes and critical process parameters into a focused risk-based approach for validation.
• Collaborate with internal partners, including Quality Assurance, Engineering, Manufacturing, and Regulatory Affairs, to ensure alignment and consistency to validation procedures and timelines.
• Support engineering activities, (e.g. support the Change Control creation) to ensure appropriate validation work is clearly defined resulting from technical changes.
• Serve as the Lead validation representative for all internal, external, or regulatory inspections/audits to ensure site readiness in support of successful inspections e.g. no critical observations related to validation activities.
• Lead commissioning, qualification, and validation activities related to medical device manufacturing and facility systems including custom automation equipment
• Build validation protocols such as FAT/SAT/IQ/OQ/PQ ensuring compliance with regulatory compliance and industry standards as needed
• Develop and implement measurement systems analysis protocol including Gage R&R (GR&R) and Attribute Agreement Analysis (AAA).
• Analyze validation data, generate validation reports, and detail any deviations or non-conformances, implementing corrective and preventive actions as needed.
• Stay up to date with current regulations, industry trends, and technological advancements in validation practices, ensuring compliance and suggesting process improvements when appropriate.
• Mentor and guide junior validation engineers, promoting professional development and collaboration.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs.; Assoc.+6yrs; M.S.+0 yrs.)
• The ability to fluently read, write, understand and communicate in English
• 2 Years of Relevant Experience
• 1 Years of Demonstrated Leadership
• Work hours: M-F
• Travel Requirements: Minimal
• Relocation assistance: None
• Sponsorship available: None

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE

• Strong Equipment qualification and process validation experience, shown experience with custom automation is desired.

HOW YOU CAN THRIVE AT ALCON:

• A career at Alcon offers focused growth and development opportunities!
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.  Join our team to help people #SeeBrilliantly!

The selected candidate will have responsibility for writing SOPs, protocols, reports, and computer system validation (CSV) documents (e.g. URS, RTM, VSR, IQOQPQ) to support GMP systems.  The candidate will also support the new LabVantage LIMS with eLN for metadata entry and day-to-day site upkeep of the system. Candidate will also support upkeep of the computerized calibration and maintenance system (ProCalV5). The candidate must be able to follow SOPs and protocols accurately and conduct work in compliance with cGMP, safety, and regulatory requirements. 

Essential Duties and Responsibilities of this job:

• Documentation writing (protocol, reports, SOPs, etc.).

• Able to follow SOP instructions in a cGMP environment.

• Communicates with equipment vendors as needed for support on new systems.

• Maintains, reviews, and approves analytical instrument calibration and maintenance records.

• Assists with creation of CSV documents as directed by site CSV lead.

• Authors technical CSV documents and utilizes Alcon systems for routing for review/approvals. 

• Conducts work in compliance with cGMP, safety, and regulatory requirements.

Required Knowledge, Skills & Abilities:

• Experience in writing. performing and reviewing laboratory equipment qualification documents.

• Experience with analytical systems (e.g. GC, HPLC, Karl Fischer, IR, pH, osmometry, and particle size).

• The candidate should be comfortable working in a fast-paced environment – able to rapidly flex activities and priorities.

• This candidate should have strong communication (written and oral) and organizational skills.

• The candidate must be able to work effectively with others cross-functionally.

Preferred Skills:

• Proficient with LIMS and eLN applications (e.g., LabVantage)

• Experience with software lifecycle activities / system development lifecycle documentation: User/Functional Requirement Specifications (U/FRS), Risk Assessments (RA), System Design and Configuration Specifications (SDCS), Design Qualification (DQ), Requirements Tracing (RTM), test script writing, summary reports, etc.

Key Requirements/Minimum Qualifications:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs) 

• The ability to fluently read, write, understand, and communicate in English

• 2 Years of Relevant Experience 

• Work hours: M-F, standard

• Travel Requirements: 0-5%

• Relocation assistance: no

• Sponsorship available: no  

#LI-DNI

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

Position Purpose / Major Accountabilities:

• Conducts process development and process upscaling studies for new medical device products

• Runs studies to gain fundamental process understanding at a Y = f(x) level and uses this process knowledge to: improve yields, reduce defects, define specifications and define user requirements for equipment

• Analyzes data to assess the sources of variation in the process and understand the cause and effect relationship between factors and responses

• Documents study design, results, next steps and process knowledge / understanding

• Communicates results and next steps to various teams within R&D

• Supports process development timeline by completing tasks on schedule

• Collaborates and partners with associates from multiple disciplines, including Engineering, Development, Research and Production, to ensure project success

Additional Accountabilities:

• Designs, executes and analyzes Engineering Studies to be performed in the lab, pilot line and MTO production lines in areas including, but not limited to: Measurement System Evaluation (MSE, GR&R), Component of Variation Studies (COV) and Design of Experiments (DOE)

• Documents study designs using graphical sampling plans and Factor Relationship Diagrams (FRDs)

• Documents process knowledge and process investigations using Thought Maps and Process Maps

• Performs data analysis including process performance index (Ppk), ANOVA, regression, Chi-square, etc.

• Applies intermediate level principles of engineering and / or chemistry analysis, blends technical knowledge and manufacturing practices in providing solutions to problems

• Position may require international travel, particularly to Germany for periods of up to two weeks per year

• Positive attitude with good interpersonal skills and ability to support a team environment

Skills / Experience:

• Proficient in MS Office

• Work experience in FDA regulated industry, specifically medical devices or contact lenses (preferred)

• Experience in statistical analysis using JMP or Minitab and / or Lean Six Sigma Green Belt (or higher)

• Experience writing, executing and analyzing Engineering Studies (preferred)

• Experience with high-speed automation (preferred)

Key Requirements/Minimum Qualifications:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)

• The ability to fluently read, write, understand and communicate in English

• 2 Years of Relevant Experience

• Work hours: M-F, standard

• Travel Requirements: Travel to Germany 1-2 weeks per year

• Relocation assistance: no

• Sponsorship available: no

#LI-DNI

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

Digital Twin of Eye is a Modeling and Simulation (M&S) driven research and development project, specifically in the area of computational human eye model development to support R&D device / therapy development and interaction with human eye.

Key Responsibilities:

• Drive our vision to develop digital twin of eye, a set of physically realistic multi-physics simulation models of human eye, that will enable accurate modeling of key aspects of ocular physiology pertaining to the interaction of the human eye with Alcon's products and systems.

• Establish future strategy and direction for digital twin of eye modeling project in alignment with R&D’s strategic plans within multiple technology platforms.

• As an expert in computational modeling and simulation (FEA and CFD) drive innovation and ensure high quality decision making through effective application of Modeling and Simulation for the eye model

• Be able to technically assess the credibility of the computational models and develop validations and verification methods.

• Partner with Alcon key leaders and senior team members to develop digital twin eye work plans and objectives for establishing models / simulations / capabilities to accomplish specific objectives for the defined area of focus in the eye.

• Develop network of external resource partners and leverage experts appropriately to accomplish work plans including - developing detailed work plans, schedules, project estimates, resource plans, and status reports, conducting risk analysis and monitoring the progress of plans against project milestones and budgets.

• Serve as an SME to drive existing digital twin of eye work streams to completion, providing technical and analytical guidance to both internal and external teams.

• Ensure projects are completed on time with expected accuracy, ensure adherence to quality standards and review of project deliverables

• Analyze and document requirements by liaising with a range of users in the organization. Manage the integration of vendor tasks and tracks and review vendor deliverables

• Develop and manage interpersonal relationships to influence decisions of technical leaders and M&S analysts along with external resources.

• Responsible for successful and innovative problem solving in resolution of the most challenging issues with a customer driven focus; champion Alcon values and behaviors.

• Collaborate with and influence project leaders in simulation driven product development with accountability for outcome.

• Demonstrated 8 years of expertise in Multiphysics Simulation methods and applications to medical devices and therapies

• Experience in biological tissue modeling. Advanced knowledge of occular physiology is a plus

• Demonstrated expertise in use of various M&S tools from providers such as Ansys, Siemens, Altair to healthcare applications

Key Requirements/Minimum Requirements

• Mechanical/Biomedical/Electrical engineer (M.S.+8 yrs; PhD+5 yrs)

• The ability to fluently read, write, understand, and communicate in English

• 3 Years of demonstrated project leadership experience

• Work hours: 40 hours

• Travel Requirements: Minimal if office based, 15% if remote

• Sponsorship available: Yes

• Relocation: No

#LI-DNI

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

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Total Rewards

Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value.  The first layer of our rewards program is compensation.  We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population.  Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.  To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click here

Pay Range

Pay Frequency

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate ambitiously, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your dedication and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, hardworking people to join Alcon! As a Senior Engineer supporting our Research and Development Engineering Team, you will be trusted with helping to develop and maintain equipment for developing new contact lens products at our manufacturing site in Johns Creek, GA.

In this role, a typical day will include:

• Developing, crafting, installing, commissioning, qualifying, validating, and optimizing ocular health laboratory and manufacturing equipment in compliance with Good Practice (GxP) procedures

• Communicating and coordinating with internal/external vendors during the implementation, commissioning, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and optimization of equipment 

• Completing tasks efficiently and working together with other departments to achieve common and overarching project goals (e.g. landmark, budget, etc.) 

• Being responsible for redefining the current maintenance concept into a paperless system using Maximo

• Assuring that there is a safe and orderly work environment and compliance with corporate rules and regulations

• Providing support as needed and generating required technical documents including Standard Operating Procedures (SOPs), training manuals, and protocols per GMP guidelines

• Troubleshooting and correcting issues related to sophisticated production equipment used in the contact lens development/manufacturing process

• Crafting maintenance plans or spare part infrastructure to reduce unplanned machine downtimes

• Maintaining equipment and repair and preventive maintenance records

• Crafting and implementing protocols for product development and preparing documentation related to procedures, training, work instructions, validations, reports, etc.

• Applying technical methods to optimize processes and sustainably improving product quality and process yields

• Having a positive demeanor with good interpersonal skills and being capable of supporting an excellent team environment

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)

• 2 Years of Relevant Experience

• The ability to fluently read, write, understand, and communicate in English

• Work hours: 40 hours per week: Monday – Friday: Exempt: 8 AM EST – 5 PM EST

• Travel Requirements: 0 to 10%

• Sponsorship & Relocation Not Available

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:

• Degree in Electrical, Mechanical, Process Engineering, or related majors

• Leadership Experience (Will need to be able to provide training opportunities and supervise direct reports)

• Experience in installation and commissioning of production equipment as well as production operations

• Excellent organizational and time management skills

• Advanced proficiency in Maximo and Microsoft Office Suite

HOW TO THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and findings as work evolves.

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

Responsibilities:

• Primary function is to manage activities associated with software changes for a variety of medical device systems.

• Manages/coordinates updates performed by development team, and incorporates updates to software, as needed.

• Ability to manage multiple small-scale projects, or a few larger projects at one time.

• Collaborate closely with software development teams (both on-shore and off-shore), Technical Support, Field Service, Manufacturing, Product Security, Clinical and other organizations to accomplish necessary software changes initiated by reported anomalies, changes in use-cases, material or hardware changes that impact software, cybersecurity, regulatory updates, and other.

• Troubleshoot, and define solutions to meet expectations, and incorporate changes according to defined processes and procedures, in line with industry standards and regulations.

• Maintain configuration management and change control according to the associated product Configuration Management Plan and Change Control procedures.

• Assure compliance to software release procedures for post-Market changes to on-market products.

• Interact with outside vendors, write/modify/convey requirements, and be able to identify and hold outside vendors accountable for their deliverables.

• On a regular basis, monitor project activities and report status, including feedback on blockers, potential changes to project scope and activities, and recommended solutions as appropriate.

• On-site presence required on a regular basis. (Occasional remote work possible, per project demands).

Experience

• BS in Computer Science or other related discipline with 3 years’ experience; or 7 years of relevant experience

• Must have experience leading software development change activities or proven leadership abilities.

• Must understand software design control and be familiar with product-level design control.

• Prefer C++ and C# development experience, and familiarity with object-oriented software design.

• Ability to work cross-functionally with a variety of stakeholders.

• Ability to work independently, proactively identify issues, recommend, and implement solutions, and deliver quality results on schedule while managing multiple tasks and internal customers. Understanding of Window operating environments (Win10, Win7, etc.).

• Experience with one or more software configuration management systems and related tools, such as: Confluence, Jenkins, AWS DevOps, Jira, Git, GitHub, TFS Knowledge of networking and cybersecurity concepts are a plus.

• Experience with Microsoft Visual Studio, ADO, or other integrated development environment (IDE) tool.

• Familiar with FDA/ISO regulations for software development, including IEC 62304 Solid understanding of Software Development Lifecycle Management (SDLC) – (Agile/Scrum, iterative).

• Excellent interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a virtual, remote, and asynchronous environment.

• Medical device experience is preferred

Key Requirements/Minimum Qualifications:

• Associates Degree or equivalent years of directly related experience.

• The ability to fluently read, write, understand, and communicate in English

• 2 years of Relevant Experience

• Work hours: M-F, standard

• Travel Requirements: 0-5%

• Relocation assistance: yes

• Sponsorship available: yes    

#LI-DNI

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Total Rewards

Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value.  The first layer of our rewards program is compensation.  We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population.  Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.  To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click here

Pay Range

Pay Frequency

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As an Associate Director, Pharmaceutical Programming in Fort Worth, TX, you will act as key leader responsible for independently managing activities and resources to ensure quality, timely and efficient execution of all statistical programming aspects of global studies and projects in a franchise or a therapeutic area (TA) and act as the strategic point of contact for Franchise, TA, Project and Trial Statisticians for the same franchise or TA

Major Accountabilities

• Provide leadership to achieve goals aligned with franchise and organizational objectives

• Serves as statistical programming expert within a franchise or TA to the broader Alcon

• Manage global associates in different Alcon locations including but not limited to Alcon Global Services centers worldwide

• Responsible for recruitment, onboarding, professional development, training, mentoring, retaining, and performance management of assigned programmers

• Understand SP deliverables, customer expectations and resource requirements. Prioritize tasks, assign resources, and manage plan to optimize resources.

• Forecast short-term and long-term demand for resources

• Generate status reports and metrics

• Lead statistical programming activities as Project Programmer or Trial Programmer as needed

• Build and maintain effective working relationships with leadership and relevant cross-functional teams. Effectively communicate the status of deliverables, changes to plan, risks, and proposed mitigation strategy

• Lead development of SP standards and processes, knowledge sharing, and other tasks as assigned

​Key Performance Indicators

• Achievement of goals aligned with franchise and organizational objectives

• Quality and timeliness of all deliverables within Franchise or TA

• Effectiveness in developing, mentoring, retaining, and managing performance growth and rewards of assigned programmers

• Accuracy of resource estimation and efficiency in resource utilization

• Effectiveness in representing SP in relevant teams and facilitating cross-functional collaboration

• Development of standards and processes that improve quality, timeliness and/or efficiency of deliverables

• Compliance with internal and external standards as measured by audit findings

​Impact in the Organization

• Timely and high-quality SP deliverables. Delays and errors in deliverables may impede submissions or other product developments and subsequent revenue loss to the company

• Efficient programming leading to quality submissions, and reduced time and costs for development and registration

• Ensuring external quality reputation of Alcon with Health Authorities

Competency Profile

• Strong leadership, collaboration, and organizational skills with proven ability to successfully manage numerous, simultaneous activities and meet deadlines

• Strong SAS programming skills including development and use of macros and experience with R programming would be helpful

• Extensive experience in requirements analysis, resource estimation, planning and tracking deliverables and coordinating activities

• Extensive experience in developing programming dataset specifications

• Good working knowledge of statistical concepts

• Good understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, ICH) and industry standards such as CDISC

• Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions

• Excellent written and oral communication

• Good skills in interviewing, mentoring, coaching, knowledge management and best practice sharing

• Pharmaceutical programming experience, 7 years of relevant programming experience, 3 years of proven ability to lead statistical programming activities as a Project Programmer and 3 years of management experience

Key Requirements/Minimum Qualifications:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs) 

• The ability to fluently read, write, understand, and communicate in English.

• 7 Years of Relevant Experience 

• Work hours: M-F, standard

• Travel Requirements: 5-10%

• Relocation assistance: yes

• Sponsorship available: yes    

#LI-DNI

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon As a Production Technician supporting LS3, you will be trusted to deliver all aspects of production processes at our Manufacturing Facility in Johns Creek, GA.

In this role, a typical day will include:

• Perform minor equipment repairs and adjustments and conduct autonomous maintenance along with 5S duties.
• Coordinate downtime to ensure efficient use for maintenance and cleaning.
• Operate production equipment, perform lot changes, and coordinate machinery downtime.
• Troubleshoot equipment faults and enter product and raw materials into MES and SAP databases.
• Work with engineers to execute equipment validations.

WHAT YOU'LL BRING TO ALCON:

• High School Diploma or Equivalent.
• The ability to fluently read, write, understand, and communicate in English.
• Work hours: 6:30PM - 6:30AM; 12-hour rotating night shift: 2 nights on, 2 nights off, and every other weekend.
• Travel Requirements: None
• Relocation assistance: No
• Sponsorship available: No

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Quality Engineer I in the Complaints Department you will be trusted to work on supporting product improvement at Sinking Spring, PA.

In this role, a typical day will include:

• Provide complaint trending analyses to support improvement of products manufactured in the facility and prepare trend reports for site Complaint Review Board.
• Maintain knowledge of product quality controls and failure modes.
• Evaluate complaint samples and provide training for complaint sample evaluations.
• Initiate and perform investigations, (Complaint investigations and Non-Conformance investigations) and Corrective Actions / Preventive Actions (CAPA) while providing guidance and approval, maintain & follow up on Quality Corrective Action Plans using Root Cause analysis tools and data evaluation.
• Provide Progress Reports and trending to show product quality levels and respond to regulatory requests.

Additional responsibilities:

• Support continuous improvement projects, quality issue resolution, Non-conformances/CAPAs, and Quality System activities for the complaint handling process.
• Use various statistical and non-statistical problem-solving tools as part of analysis of data, issues, or improvement opportunities.
• Actively participate and chip into routine platform-based meetings and change control activities.
• Provide Quality Assurance support and guidance on medical device products, process, and document changes to assure compliance with site Quality Systems procedures.
• Consistent track record to handle time efficiently and meet target quotas under pressure.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs.; Assoc.+4 yrs.)
• The ability to fluently read, write, understand and communicate in English
• Work hours: M-F
• Travel Requirements: Minimal
• Relocation assistance: No
• Sponsorship available: No

HOW YOU CAN THRIVE AT ALCON:

• See your career like never before with focused growth and development opportunities
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Principal Device Engineer, supporting the Dry Eye and Ocular Health portfolio within the Vision Care franchise, you will be trusted to lead design and development of novel ophthalmic devices (including novel packaging/ delivery devices) and effectively integrate all physical, mechanical, and electronic (as applicable) aspects of device at our Main Campus in Fort Worth, TX.

In this role, a typical day will include:

• Responsible for executing device engineering activities for ocular health related new products.
• Support research & development in the area of novel ophthalmic devices (including novel packaging/ delivery devices)
• Interact with external consultant(s) and contractors to develop technology and conduct and/or lead necessary research leading to device commercialization.
• Generate and analyze data from laboratory and simulation and provide technical guidance.
• Provide device technical support and be accountable for all device engineering related deliverables within the assigned projects’ activities, according to regulatory and mandatory industry performance standards.
• Design, generate, analyze, and report data from laboratory and simulation and provide technical guidance in support of global product development and registration including any testing required to support global registration.
• Hands-on experience in design and execution of experiments.
• Possess a comprehensive knowledge of device development, material properties, fluid mechanics, and critical quality attributes that can impact the performance of the products.
• Support and lead the device related regulatory document preparation for registration dossiers and brand related medical information, communication, publications (510(k), CE Mark, Japan, CTD’s, Envisa’s, NDA, IND, etc) Ensuring timely responses to Health Authorities questions for support of regulatory dossiers.
• Support and lead the device(s) related document preparation for Investigator Brochures (IB) in support of clinical studies.
• Support existing device and ophthalmic packaging by addressing select product support requests and addressing questions on existing products.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• The ability to fluently read, write, understand, and communicate in English.
• 7 Years of Relevant Experience
• Work hours: Exempt- Mon-Fri
• Travel Requirements: 10-15%
• Relocation assistance: Yes
• Sponsorship available: No

PREFERRED QUALIFICATIONS:

• Experience in Medical Device Design and Development preferred.
• Proficiency in CAD. SolidWorks or Creo preferred.
• Strong understanding of mechanical engineering principals, materials, fluidics, etc.
• Demonstrated skill in engineering design tools, modelling, engineering analysis, etc.
• Ability to work under minimum oversight to identify and prioritize work activities as necessary to achieve project goals within set timelines.
• Ability to produce high quality work output capable of meeting project needs, even when operating under tight timelines.
• Successfully provide design leadership to new ophthalmic product development projects.
• Work efficiently and productively with other team members and external partners.
• Adheres to Alcon's guidelines for appropriate workplace behaviors and attitudes.
• Ability to operate and influence cross-functionally, cross-culturally, and in matrix organizations.
• Candidates who have both medical device and fluid system design backgrounds will be given preference.

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and findings as work evolves.
• See your career like never before with focused growth and development opportunities.
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off (FTO) and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.