Specialist, Associate Process Engineer in Devens, MA

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.

• BSc and/or MSc in Science or Chem/Bio Engineering.
• 0–3 years industry experience; cGMP and/or Cell Therapy manufacturing experience preferred.

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.

If the role doesn’t perfectly match your resume, you are encouraged to apply.