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

Role Summary

The Specialist, Associate Process Engineer, Cell Therapy provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. The Associate Process Engineer works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions. Other responsibilities include participation in process tech transfer, supports incoming process changes by communicating the changes to applicable departments, and participates in process improvement projects at the site. The process engineer works to identify and drive continuous improvements to the manufacturing process. Location: Devens, MA.

Responsibilities

• Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
• 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
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts
• Interfaces with other functions such as 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 on impact assessments

Qualifications

• Required: Minimum 0-3 years of industry experience
• Preferred: cGMP and/or Cell Therapy manufacturing experience

Education

• BSc and/or MSc degree in Science or Chem/Bio Engineering

Skills

• Troubleshooting and technical support on the manufacturing floor
• Data analysis to support impact assessments and investigations
• Change control and CAPA ownership
• Authoring and revising SOPs and electronic batch records
• Technology transfer and process improvement
• Training GMP operators on new procedures
• Continuous improvement and process optimization
• Cross-functional collaboration (Scheduling, Global MSAT, Supply Chain, Quality, Facilities & Engineering)
• Equipment and systems validation support
• Gowning and plant access; awareness of magnetic field exposure in manufacturing areas

Additional Requirements

• Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.