Senior Specialist, Associate Process Engineer II

Process Engineers provide technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment, including troubleshooting process/equipment issues, determining immediate corrective actions for deviations, identifying root cause, and implementing long-term preventive actions. Support process tech transfer, communicate incoming process changes, and participate in process improvement projects to drive continuous improvements.

Responsibilities will include (but are not limited to):
- On-the-floor/on-site troubleshooting and technical support to Manufacturing
- Deviation prevention and deviation closure through site quality systems
- Analyze/summarize manufacturing data for impact assessments and investigations
- Owner of routine change controls; CAPA owner for Manufacturing improvements
- Author/revise manufacturing SOPs and provide technical direction for electronic batch records
- Participate in technology transfer; train/support GMP operators on new procedures/changes
- Use continuous improvement tools to close procedural/compliance gaps
- Identify process improvements/operational efficiencies and lead implementation
- Interface with Scheduling, Global MSAT, Supply Chain, Quality, Facilities & Engineering
- Support equipment/systems validation (review qualification docs, draft URs, participate in impact assessments)
- Gowning and entering manufacturing plant; exposure to strong magnetic fields

Minimum Requirements:
- BSc and/or MSc in Science or Chem/Bio Engineering
- 2.5+ years industry experience; at least 1 year relevant experience in GMP biologic/cell therapy manufacturing technical/process support (cGMP and/or cell therapy manufacturing preferred)

Compensation Overview:
- Devens, MA (US): $87,660–$106,224

Benefits (high level): Health coverage; wellbeing support; 401(k), disability, life/accident insurance; Paid time off.

Application instruction: If you’re interested but don’t perfectly match, apply anyway.