Manager, Aseptic Process Engineer in Devens, MA

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. 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.

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, there’s no better place than here at BMS with our Cell Therapy team.

The Manager, Aseptic Process Engineer leads the aseptic process validation program for the Devens Cell Therapy Facility (CTF).

Shifts Available:

Monday - Friday, 8:30am - 5pm

Responsibilities:

• Responsible for CTF Validation activities including, but not limited to Aseptic Process Simulations/ Validations (APS/APV) and Aseptic Performance Qualifications
• Performs data analysis, including the use of statistics, and prepares written protocols/reports/summaries supporting validation studies.
• Leads/Owns site Change Controls
• Participates in/Leads aseptic risk assessments and authors qualification/ validation documents (e.g. procedures, protocols and reports) in accordance with internal and external regulatory expectations. 
• Supports investigations and global change controls as required.
• Ensures safe and compliant cGMP operations, maintains permanent inspection readiness, and actively supports regulatory inspections as a Subject Matter Expert.
• Identifies, prioritizes and drives continuous improvements that reduce safety risks, operational costs, lead times, scrap, and discrepancy rates across all aspects of production. Promotes problem identification and the creation of meaningful solutions through a culture of proactive problem prevention.
• Serves as a MS&T representative on cross-functional and multi-site teams
• Builds and maintains effective collaborative relationships across the site and network, influencing site and network product/process life cycle programs

Knowledge and Skills:

• Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
• Experience in facility/clean room design, aseptic processing, and validation.
• Experience in assessing and implementing product/process lifecycle changes
• Experience with internal and health authority audits, particularly pre-licensure inspections (PLIs)
• Excellent verbal/written communication skills and ability to influence at all levels

Basic Requirements:

• Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline, or its equivalent is required
• A minimum of 5 years’ experience in biopharmaceutical operations or its equivalent is required

The starting compensation for this job is a range from $114,290 - $138,500, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://career