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Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer II in Devens, MA, to support the qualification of manufacturing and laboratory equipment in a regulated environment. The role involves developing validation deliverables, maintaining compliance with industry guidelines, and fostering collaborative relationships within teams and with external partners.
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Job Summary
The role supports the implementation of manufacturing and laboratory equipment alongside facilities and utilities at multi-use sites.
Candidates will develop and execute validation deliverables such as Validation Plans, Requirements Specifications, and Summary Reports.
Bristol Myers Squibb offers a wide variety of competitive benefits including health coverage, financial well-being programs, and flexible time off.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Senior Specialist, Validation Engineer II in Devens, MA, to support the qualification of manufacturing and laboratory equipment in a regulated environment. The role involves developing validation deliverables, maintaining compliance with industry guidelines, and fostering collaborative relationships within teams and with external partners.
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Salary
Base: $92,540 - $112,136; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off
Skills & Requirements
Must-have
Bachelor of Science in Engineering required
3+ years FDA regulated manufacturing experience
2+ years equipment facility utility qualification
Knowledge of cGMP and validation lifecycle
Experience with change control and CAPA
Nice-to-have
Familiarity with Lean principles and Six Sigma
Knowledge of GAMP automation validation concepts
Experience with biologics or cell therapy facilities
Ability to work as SME in regulatory audits
Key Requirements
Bachelor of Science degree in Chemical or Mechanical Engineering
Minimum 3 years relevant experience in FDA regulated manufacturing
Minimum 2 years experience in equipment, facility, or utility qualification