Senior Manager, Senior Process Engineer, Cell Therapy
Bristol Myers SquibbAbout the role
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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: careers.bms.com/working-with-us.
PURPOSE AND SCOPE OF POSITION:
The Sr. Process Engineer 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 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 and incoming process changes, communicate the changes to applicable departments, and lead the process improvement projects at the site. The process engineer works to identify and drive continuous improvements to the manufacturing process.
DUTIES AND RESPONSIBILITIES
- Functions as a technology and process subject matter expert
- Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing
- Facilitate 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 process and procedure changes
- CAPA owner for Manufacturing improvements
- Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
- Leads 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.
- Represent MSAT and interface 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
EDUCATION AND EXPERIENCE
- BSc and/or MSc degree in Science or Chem/Bio Engineering
- Minimum 8 years of industry experience. Cell Therapy manufacturing experience preferred.
- Minimum 6 years relevant experience in GMP biologic manufacturing technical or process support.
- Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.
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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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
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With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary.
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