Senior Specialist, Associate Process Engineer II

PURPOSE AND SCOPE OF POSITION:
Process Engineers provide technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. Troubleshoot process/equipment issues; partner with Manufacturing and Quality to determine corrective actions for deviations, identify root cause, and implement preventive actions. Participate in process tech transfer, communicate incoming process changes, and drive continuous improvements.

RESPONSIBILITIES / DUTIES:
- On-the-floor troubleshooting and technical support to Manufacturing
- Deviation prevention and deviation closure via site quality systems
- Analyze/summarize manufacturing data for impact assessments and investigations
- Own routine change controls for process/procedure changes
- Own CAPA for Manufacturing improvements
- Author/revise manufacturing SOPs; provide technical direction for electronic batch records
- Participate in technology transfer; train/support GMP operators on new procedures/changes
- Apply continuous improvement tools; lead implementation of process/efficiency opportunities
- Interface with Scheduling, Global MSAT, Supply Chain, Quality, Facilities & Engineering
- Support equipment/systems validation (review qualification documents, draft URs, impact assessments)
- Perform gowning, enter manufacturing plant; exposure to strong magnetic fields

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

PREFERRED QUALIFICATIONS:
- cGMP and/or Cell Therapy manufacturing experience

BENEFITS (explicitly stated):
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k); disability and life insurance
- Paid time off (incl. flexible time off and national holidays; details vary by location/role)