Bristol Myers Squibb is reimagining the future of cell therapy, aiming to unlock the full promise of this innovative treatment. The Specialist, Engineer I role involves supporting the production of personalized cell therapy products for clinical trials and commercial supply, focusing on process support, documentation, and cross-functional collaboration.
Responsibilities
- Provide remote process support for ongoing manufacturing activities when needed
- Ability to provide floor process support in exception cases
- Interface with Manufacturing operations and QA Shopfloor and serve as process SME
- Lead product impact assessments to support investigations
- Support lifecycle management project implementation at a site level to accomplish drug product harmonization across sites and evolve process
- Support the change initiatives and the implementation of process improvement initiatives
- Foster strong inter-team relationships to achieve common project goals
- Support process monitoring initiatives including but not limited to developing and collecting data. Analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production
- Execute test plans, change controls, and other risk mitigation exercises as part of investigations (e.g. Root cause analysis and CAPAs)
- Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities
- Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations
- Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records)
- Interact with other teams including Technical Product Team, Validation, Development, Operations, QA and Regulatory
- Participate in routine plant operating meetings (i.e. Tiers, Townhalls, MSAT Extended Staff, etc.)
- Proven ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely
- Ability to set priorities, manage timelines and effectively react/manage changing priorities
- Ability to work with management (global and site) and support corporate and departmental goals
- Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers
- Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control. Proven delivery of complex investigation reports
Skills
- Bachelor's Degree required (science or engineering is preferred)
- 1 year of relevant experience within a manufacturing GMP facility
- Technical Writing skills
- Proven ability to understand, follow, interpret, and apply Global Regulatory and cGMP requirements accurately and completely
- Ability to set priorities, manage timelines and effectively react/manage changing priorities
- Ability to work with management (global and site) and support corporate and departmental goals
- Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers
- Knowledge of cGMPs and multi-national biopharmaceutical regulations
- Must have excellent organization skills and ability to handle multiple tasks
- Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
- Experience working with external parties and/or leading cross-functional teams
- Possess strong verbal/written communication skills and ability to influence at all levels
- Ability to think strategically and to translate strategy into actions
- Ability to prioritize and provide clear direction to team members in a highly dynamic environment
- Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control
- Knowledge of the relationship between manufacturing processes, ERP, and MES a major plus
- Cell therapy experience is a major plus
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.
- Paid Time Off
- Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.
Company Overview
At Bristol Myers Squibb, we work every day to transform patients’ lives through science. It was founded in 1887, and is headquartered in New York, New York, USA, with a workforce of 10001+ employees. Its website is http://www.bms.com.Company H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships, with 247 in 2025, 278 in 2024, 231 in 2023, 180 in 2022, 181 in 2021, 169 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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