Specialist, Engineer I
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
Company H1B Sponsorship