Specialist, Associate Process Engineer Devens MA

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At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition backed by a best-in-the-industry team and long-term commitment we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself accelerate your career and give new hope to patients theres no better place than here at BMS with our Cell Therapy team.

The Specialist Associate Process Engineer Cell Therapy provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process. 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.

Shifts Available:

TBD

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