Specialist, Associate Process Engineer, Cell Therapy in Devens, MA
Bristol Myers Squibb
Full-time
Remote friendly (Devens, MA)
United States
Operations
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Role Summary
The Specialist, Associate Process Engineer, Cell Therapy provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. Works with Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions. Participates in process tech transfer, supports incoming process changes, and engages in process improvement projects to drive continuous manufacturing enhancements.
Responsibilities
- Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
- Facilitates deviation prevention and deviation closure through site quality systems
- Analyze and summarize manufacturing data to support impact assessments and investigations
- Owner of change controls for routine process and procedure changes
- CAPA owner for Manufacturing improvements
- Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
- Participates in technology transfer efforts for new processes and product implementation
- Train and support GMP operators on new procedures, processes, and changes
- Applies continuous improvement tools to identify and close procedural and compliance gaps
- Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts
- Interfaces with Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
- Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments
- Ability to perform gowning activities and enter the manufacturing plant; exposure to strong magnetic fields in manufacturing areas
Qualifications
- Basic Requirements: BSc and/or MSc degree in Science or Chemical/Bio Engineering
- Minimum 0-3 years of industry experience; cGMP and/or Cell Therapy manufacturing experience preferred