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Specialist, Engineer , MSAT Process Engineering

Job in Summit, Union County, New Jersey, 07902, USA
Listing for: Bristol Myers Squibb
Full Time position
Listed on 2026-03-08
Job specializations:
  • Business
    Data Analyst
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
Job Description & How to Apply Below
Position: Specialist, Engineer I, MSAT Process Engineering

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 grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. 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. We are reimagining the future of cell therapy, leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure.

If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team.

This role is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Potential areas of responsibility include day‑to‑day manufacturing support, leading manufacturing investigations related to the process control strategy, and supporting lifecycle management of MBRs. These areas can include creation or revision of documentation (e.g., SOP, validation documentation, technical reports) required to support the production of personalized cell therapy products.

Cross‑functional collaboration with SMEs from the Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR‑T manufacturing organization.

Shift Available
  • Monday – Friday, Hybrid Day Shift, 9 a.m. – 5 p.m.
Responsibilities
  • Provide on‑floor or remote process support for ongoing manufacturing activities when needed.
  • Support deviation investigations utilizing root cause analysis tools.
  • Lead product impact assessments to support investigations.
  • Become a process SME and interface with operations and QA shop floor.
  • Support process monitoring initiatives, including collecting data, optimizing the end‑to‑end process, and permanently resolving issues during production.
  • Accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
  • Support health authority and/or internal inspections.
  • Assist in maintaining Manufacturing Batch Records (MBRs) and/or Electronic Batch Records, including specifications, process parameters, instructions, and process variables.
  • Organize, record, and maintain experimental data.
  • Assist with revisions of technical documentation (e.g., change actions, SOPs, batch records).
  • Support lifecycle management project implementation at a site level.
  • Participate in project teams to prepare project schedules, execute technical projects, and develop presentations to disseminate results to stakeholders and senior management.
  • Support change initiatives and the implementation of process improvement initiatives.
  • Foster strong inter‑team relationships to achieve common project goals.
  • Interface with other teams, including Technical Product Team, Validation, Development, Operations, QA, and Regulatory.
  • Participate in routine plant operating meetings (Tiers, Townhalls, MSAT Extended Staff, etc.).
  • Communicate honestly, transparently, and effectively with peers, department management, and cross‑functional peers.
  • Stay current with industry trends and standards (e.g., PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
  • Set priorities, manage timelines, and react/manage changing priorities.
  • Work with management (global and site) and support corporate and departmental goals.
Knowledge & Skills
  • Knowledge of cGMPs and multi‑national biopharmaceutical regulations. Cell therapy experience is a major plus.
  • Knowledge of the relationship between manufacturing processes, ERP, and MES.
  • Excellent…
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