Senior Specialist, Associate Process Engineer II

Bristol Myers Squibb • Devens, MA

1d • Onsite

About The Position

Process Engineers provide 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. Process Engineers work 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. Process engineers work to identify and drive continuous improvements to the manufacturing process.

Requirements

• Minimum 2.5+ years of industry experience with a minimum of 1 year of relevant experience in GMP biologic/cell therapy manufacturing technical or process support.

Nice To Haves

• cGMP and/or Cell Therapy manufacturing experience preferred.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree