Senior Manager, Senior Process Engineer, Cell Therapy

Bristol Myers Squibb • Devens, MA

13h

About The 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 Sr. 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 Sr. Process engineer works to identify and drive continuous improvements to the manufacturing process. This position may lead a small team of process engineers that support 24/7 cell therapy operations.

Requirements

• Minimum 8 years of industry experience. Cell Therapy manufacturing experience preferred.
• Minimum 6 years relevant experience in GMP biologic manufacturing technical or process support.
• 1+ years managing direct report.
• Experience with Operational Excellence and Lean Manufacturing.
• Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.
• BSc and/or MSc degree in Science or Chem/Bio Engineering

Nice To Haves

• Cell Therapy manufacturing experience preferred.

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.
• Support to establish and track performance metrics for the team.
• Provide leadership and guidance to manufacturing support team as needed.
• Create an environment of teamwork, open communication, and a sense of urgency.
• Support the change agent in promoting flexibility, creativity, and accountability.
• Support organizational strategic goals and objectives that are linked to the overall company strategy.
• Drive strong collaboration within the plant and across the network.
• Build trust and effective relationships with peers and stakeholders.
• Deliver business results through timely and quality decision making and advice.
• Foster a culture of compliance and strong environmental, health, and safety performance.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level