Working with Us
Challenging. Meaningful. Life‑changing. Working at Bristol Myers Squibb is anything but usual. Every day you will help transform patients’ lives and advance the careers of the people who do it—whether by optimizing a production line or pushing the latest breakthroughs in cell therapy. You'll grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams.
Position Summary The Quality Engineering team provides quality oversight of engineering and validation lifecycle activities—including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer.
The Senior Specialist, Quality Engineering drives this oversight.
Duties / Responsibilities
Review and approve commissioning and qualification lifecycle documentation for site facilities, equipment, and utilities—including impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, and requalification.
Review and approve computer validation lifecycle documentation for site, standalone, and site‑based computerized systems—including system classification, user requirements, functional specifications, installation qualification, operational qualification/system testing, user acceptance testing, performance qualification, and periodic reviews.
Participate in risk, data‑integrity, and technical report reviews for qualification.
Perform routine quality review and approval activities for equipment/system onboarding and status.
Identify improvement opportunities and support execution of continuous‑improvement goals and projects.
Review or provide impact assessment for site change controls.
Support internal and external inspections as required.
Maintain compliance with learning plans.
li>Support integration of newer team members. Lead meetings and represent the function at cross‑functional meetings; share data and knowledge across teams; build and maintain strong relationships with partner functions.
Reporting Relationship The role is stationed in Devens, MA and reports to the Associate Director of Quality Engineering for the Devens Cell Therapy Facility.
Knowledge, Skills & Abilities
Research, understand, interpret and apply internal policies and regulatory guidelines.
Proficient with MS Office and other digital tools; quick learner of new software.
Ability to interpret data, assess technical conclusions, and provide constructive feedback.
Strong verbal and technical writing skills; able to prepare clear communications and present technical data.
Work effectively in a fast‑paced team environment; adapt to changing priorities.
Detail oriented, task focused, and meet deadlines.
Collaborate across functional groups to ensure requirements are met.
Self‑motivated and contribute to a positive team environment.
Make sound decisions for minor issues; recognize and solve quality issues.
Curious and think critically to create innovative solutions.
Education / Experience / Certifications
Bachelor’s degree in a STEM field preferred; high‑school diploma or associate’s degree with equivalent experience may be considered.
4+ years of experience in a regulated industry with at least 1 year relevant to FDA/EMA regulations in biopharmaceuticals or cell‑therapy manufacturing.
Demonstrated experience with electronic validation documentation systems.
Compensation Overview Devens, MA – $84,510 to $102,403 (base salary).
Additional incentive cash and stock opportunities may be available.
Final compensation is based on demonstrated experience.
Benefits Offerings
Health coverage: medical, pharmacy, dental, and vision care.
Well‑being support programs (BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Program).
Financial protection: 401(k) plan, disability, life & accident insurance, supplemental health, identity‑theft protection, legal support.
Paid time off: paid holidays, annual vacation, sick leave, volunteer days, and a global shutdown holiday.
Additional flexible time and summer hours for eligible U.S. employees.
EEO Statement BMS is an equal opportunity employer and encourages applicants with diverse backgrounds.
Please review our
Equal Employment Opportunity
statement at
career site .
We consider qualified applicants with arrest and conviction records in accordance with applicable laws.
#J-18808-Ljbffr
Position Summary The Quality Engineering team provides quality oversight of engineering and validation lifecycle activities—including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer.
The Senior Specialist, Quality Engineering drives this oversight.
Duties / Responsibilities
Review and approve commissioning and qualification lifecycle documentation for site facilities, equipment, and utilities—including impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, and requalification.
Review and approve computer validation lifecycle documentation for site, standalone, and site‑based computerized systems—including system classification, user requirements, functional specifications, installation qualification, operational qualification/system testing, user acceptance testing, performance qualification, and periodic reviews.
Participate in risk, data‑integrity, and technical report reviews for qualification.
Perform routine quality review and approval activities for equipment/system onboarding and status.
Identify improvement opportunities and support execution of continuous‑improvement goals and projects.
Review or provide impact assessment for site change controls.
Support internal and external inspections as required.
Maintain compliance with learning plans.
li>Support integration of newer team members. Lead meetings and represent the function at cross‑functional meetings; share data and knowledge across teams; build and maintain strong relationships with partner functions.
Reporting Relationship The role is stationed in Devens, MA and reports to the Associate Director of Quality Engineering for the Devens Cell Therapy Facility.
Knowledge, Skills & Abilities
Research, understand, interpret and apply internal policies and regulatory guidelines.
Proficient with MS Office and other digital tools; quick learner of new software.
Ability to interpret data, assess technical conclusions, and provide constructive feedback.
Strong verbal and technical writing skills; able to prepare clear communications and present technical data.
Work effectively in a fast‑paced team environment; adapt to changing priorities.
Detail oriented, task focused, and meet deadlines.
Collaborate across functional groups to ensure requirements are met.
Self‑motivated and contribute to a positive team environment.
Make sound decisions for minor issues; recognize and solve quality issues.
Curious and think critically to create innovative solutions.
Education / Experience / Certifications
Bachelor’s degree in a STEM field preferred; high‑school diploma or associate’s degree with equivalent experience may be considered.
4+ years of experience in a regulated industry with at least 1 year relevant to FDA/EMA regulations in biopharmaceuticals or cell‑therapy manufacturing.
Demonstrated experience with electronic validation documentation systems.
Compensation Overview Devens, MA – $84,510 to $102,403 (base salary).
Additional incentive cash and stock opportunities may be available.
Final compensation is based on demonstrated experience.
Benefits Offerings
Health coverage: medical, pharmacy, dental, and vision care.
Well‑being support programs (BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Program).
Financial protection: 401(k) plan, disability, life & accident insurance, supplemental health, identity‑theft protection, legal support.
Paid time off: paid holidays, annual vacation, sick leave, volunteer days, and a global shutdown holiday.
Additional flexible time and summer hours for eligible U.S. employees.
EEO Statement BMS is an equal opportunity employer and encourages applicants with diverse backgrounds.
Please review our
Equal Employment Opportunity
statement at
career site .
We consider qualified applicants with arrest and conviction records in accordance with applicable laws.
#J-18808-Ljbffr