Specialist, Associate Operations Process Engineer, Cell Therapy

Posted:
10/10/2024, 6:45:57 AM

Location(s):
Massachusetts, United States

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Operations & Logistics

Workplace Type:
Hybrid

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 rich in diversity. 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.

Position Summary

The Associate Operations 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, 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.

**12-hour shifts with rotating weekends**

**6PM-6AM or 6AM-6PM**

Key Responsibilities

  • Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign support for variable shifts (Panama schedule, 0600 to 1800 or 1800 to 0600 variable shifting of days coverage)
  • 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.


Qualifications & Experience
EDUCATION AND EXPERIENCE

  • 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

BMSCART

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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