Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA

Bristol Myers Squibb • Devens, MA

76d • $43 - $53

About The Position

The Specialist, Associate Operations Process Engineer, Cell Therapy 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, in facility. The Associate Operations 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, supporting incoming process changes by communicating the changes to applicable departments, and participating in process improvement projects at the site. The process engineer works to identify and drive continuous improvements to the manufacturing process.

Requirements

• BSc and/or MSc degree in Science or Chem/Bio Engineering.
• Minimum 1+ years of industry experience.
• cGMP and/or Cell Therapy manufacturing experience preferred.

Responsibilities

• Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign support for variable shifts.
• 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.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees