Specialist, Associate Process Engineer in Devens, MA
Bristol Myers Squibb
8 hours ago
On-site
Devens, MA
Operations
Specialist, Associate Process Engineer, Cell Therapy — Devens Cell Therapy Facility (CTF)
Responsibilities:
- Provide on-the-floor/on-site troubleshooting and technical support to Manufacturing in a GMP environment.
- Facilitate deviation prevention and deviation closure through site quality systems.
- Analyze and summarize manufacturing data to support impact assessments and investigations.
- Own routine change controls for process/procedure changes; own CAPA for Manufacturing improvements.
- Author/revise manufacturing SOPs; provide technical content and direction for electronic batch records.
- Participate in process tech transfer and support incoming process changes.
- Train and support GMP operators on new/changed procedures and processes.
- Apply continuous improvement tools to close procedural/compliance gaps; lead implementation of process improvements/efficiencies.
- Interface with Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering.
- Support equipment and systems validation (review qualification documents, draft user requirements, participate in impact assessments).
- Perform gowning and enter the manufacturing plant; exposure to strong magnetic fields is common.
Minimum Requirements:
- BSc and/or MSc in Science or Chem/Bio Engineering.
- 0–3 years industry experience; cGMP and/or Cell Therapy manufacturing experience preferred.
Compensation/Benefits (as stated):
- Devens, MA: $79,150–$95,914.
- Health coverage; wellbeing support; 401(k), disability and life insurance, etc.; Paid Time Off (including flexible time off for US Exempt employees) and Global Shutdown.
Application Instructions:
- If the role doesn’t perfectly match your resume, you are encouraged to apply.
Responsibilities:
- Provide on-the-floor/on-site troubleshooting and technical support to Manufacturing in a GMP environment.
- Facilitate deviation prevention and deviation closure through site quality systems.
- Analyze and summarize manufacturing data to support impact assessments and investigations.
- Own routine change controls for process/procedure changes; own CAPA for Manufacturing improvements.
- Author/revise manufacturing SOPs; provide technical content and direction for electronic batch records.
- Participate in process tech transfer and support incoming process changes.
- Train and support GMP operators on new/changed procedures and processes.
- Apply continuous improvement tools to close procedural/compliance gaps; lead implementation of process improvements/efficiencies.
- Interface with Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering.
- Support equipment and systems validation (review qualification documents, draft user requirements, participate in impact assessments).
- Perform gowning and enter the manufacturing plant; exposure to strong magnetic fields is common.
Minimum Requirements:
- BSc and/or MSc in Science or Chem/Bio Engineering.
- 0–3 years industry experience; cGMP and/or Cell Therapy manufacturing experience preferred.
Compensation/Benefits (as stated):
- Devens, MA: $79,150–$95,914.
- Health coverage; wellbeing support; 401(k), disability and life insurance, etc.; Paid Time Off (including flexible time off for US Exempt employees) and Global Shutdown.
Application Instructions:
- If the role doesn’t perfectly match your resume, you are encouraged to apply.