Senior Specialist, Associate Process Validation Engineer in Devens, MA
Bristol Myers Squibb
Full-time
On-site
Devens, MA
Operations
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Senior Specialist, Associate Process Validation Engineer in Devens, MA
Company: Bristol Myers Squibb
Job Overview
The Senior Specialist, Associate Process Validation Engineer, Cell Therapy provides process validation support to the Devens Cell Therapy Facility (CTF).
Responsibilities
- Overseeing Process Performance Qualifications (PPQ)
- Capacity Increases
- Tech Transfers
- Lifecycle Management changes
- Data analysis
- Preparing validation protocols/reports
- Leading change controls
- Supporting facility/equipment commissioning and validation
Requirements
- Bachelor's degree in science or engineering
- At least two years of biopharmaceutical operations experience
- Knowledge of cGMPs, biopharmaceutical regulations, and validation processes