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. 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 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. #J-18808-Ljbffr Dormont Manufacturing Co