Cell Therapy Process Engineer, Manufacturing Technology, Devens, Massachusetts

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

PURPOSE AND SCOPE OF POSITION:

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

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

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

Experience

• Minimum 5 years of industry experience. Cell Therapy manufacturing experience preferred.
• Minimum 3 years relevant experience in GMP biologic manufacturing technical or processsupport.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.