Senior Manager, Senior Process Engineer, Cell Therapy
Bristol Myers Squibb
2 days ago
On-site
Devens, MA
Operations
PURPOSE AND SCOPE
Sr. Process Engineer provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment, including troubleshooting process/equipment issues, driving deviation corrective/preventive actions, leading process improvement, and supporting 24/7 operations (may lead a small team of process engineers).
DUTIES / RESPONSIBILITIES
- Subject matter expert; provide on-the-floor/on-site troubleshooting to Manufacturing.
- Facilitate deviation prevention and closure; perform root cause analysis.
- Owner of change controls (process/procedure) and CAPAs for Manufacturing improvements.
- Analyze manufacturing data for impact assessments/investigations.
- Author/revise manufacturing SOPs; direct technical content for electronic batch records.
- Lead technology transfer and process/procedure incoming changes; train GMP operators.
- Apply continuous improvement/lean tools; identify and implement process efficiencies.
- Represent MSAT; interface with Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering.
- Support equipment/systems validation (URs, impact assessments, equipment qualification document review).
- Support performance metrics; leadership/guidance and compliance/EHS culture.
QUALIFICATIONS (Required / Preferred)
- Minimum 8 years industry experience (Cell Therapy manufacturing preferred).
- Minimum 6 years GMP biologic manufacturing technical/process support.
- 1+ years managing direct reports.
- BSc and/or MSc in Science or Chem/Bio Engineering.
- Experience with Operational Excellence and Lean Manufacturing.
- Ability to perform gowning and enter manufacturing plant; exposure to strong magnetic fields.
BENEFITS (as stated)
- Health coverage; wellbeing and Employee Assistance Programs; 401(k), disability/life/insurance protections.
- Paid time off (flexible time off or vacation depending on location/role type).
COMPENSATION
Devens, MA: US $139,480–$169,013.
APPLICATION INSTRUCTIONS
N/A in provided text (excluded legal/contact boilerplate).
Sr. Process Engineer provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment, including troubleshooting process/equipment issues, driving deviation corrective/preventive actions, leading process improvement, and supporting 24/7 operations (may lead a small team of process engineers).
DUTIES / RESPONSIBILITIES
- Subject matter expert; provide on-the-floor/on-site troubleshooting to Manufacturing.
- Facilitate deviation prevention and closure; perform root cause analysis.
- Owner of change controls (process/procedure) and CAPAs for Manufacturing improvements.
- Analyze manufacturing data for impact assessments/investigations.
- Author/revise manufacturing SOPs; direct technical content for electronic batch records.
- Lead technology transfer and process/procedure incoming changes; train GMP operators.
- Apply continuous improvement/lean tools; identify and implement process efficiencies.
- Represent MSAT; interface with Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering.
- Support equipment/systems validation (URs, impact assessments, equipment qualification document review).
- Support performance metrics; leadership/guidance and compliance/EHS culture.
QUALIFICATIONS (Required / Preferred)
- Minimum 8 years industry experience (Cell Therapy manufacturing preferred).
- Minimum 6 years GMP biologic manufacturing technical/process support.
- 1+ years managing direct reports.
- BSc and/or MSc in Science or Chem/Bio Engineering.
- Experience with Operational Excellence and Lean Manufacturing.
- Ability to perform gowning and enter manufacturing plant; exposure to strong magnetic fields.
BENEFITS (as stated)
- Health coverage; wellbeing and Employee Assistance Programs; 401(k), disability/life/insurance protections.
- Paid time off (flexible time off or vacation depending on location/role type).
COMPENSATION
Devens, MA: US $139,480–$169,013.
APPLICATION INSTRUCTIONS
N/A in provided text (excluded legal/contact boilerplate).