Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA

Role Summary

The Specialist, Associate Operations Process Engineer, Cell Therapy provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. This role includes troubleshooting process and equipment issues, collaborating with Manufacturing and Quality teams to determine immediate corrective actions, identifying root causes, and implementing long-term preventive actions. It also involves participating in process tech transfer, communicating changes to applicable departments, and driving continuous improvements to the manufacturing process. Location: Devens, MA. Shifts available: Day (6am–6pm) and Night (6pm–6am) with rotating holidays and weekends.

Responsibilities

• Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing and process campaigns across variable shifts
• Facilitates deviation prevention and deviation closure through site quality systems
• Analyze and summarize manufacturing data to support impact assessments and investigations
• Owner of change controls for routine process and procedure changes
• CAPA owner for Manufacturing improvements
• Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
• Participates in technology transfer efforts for new processes and product implementation
• Train and support GMP operators on new procedures, processes, and changes
• Apply continuous improvement tools to identify and close procedural and compliance gaps
• Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts
• Interface with Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
• Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating in impact assessments
• Ability to perform gowning activities and enter the manufacturing plant; exposure to strong magnetic fields in manufacturing areas

Qualifications

• Required: BSc and/or MSc degree in Science or Chemistry/Bio Engineering
• Required: Minimum 1+ years of industry experience; cGMP and/or Cell Therapy manufacturing experience preferred