Specialist, Associate Process Engineer in Devens, MA

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: 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.

Minimum Requirements:

• BSc and/or MSc degree in Science or Chem/Bio Engineering
• Minimum 0-3 years of industry experience. cGMP and/or Cell Therapy manufacturing experience preferred.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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