Process Engineer I

Bristol Myers Squibb • Seattle 400 Dexter, WA

79d • $108,030 - $130,903 • Hybrid

About The Position

Cell Therapy Technical Operations (CTTO) is seeking a highly motivated Process Engineer I to provide technical leadership for gene delivery and editing products. This role will be responsible for supporting process and technology transfers, leading commercialization activities, and providing end-to-end technical process support across the product lifecycle. The successful candidate will serve as a technical Subject Matter Expert (SME), partnering with internal and external stakeholders to ensure robust, compliant, and scalable viral vector processes. The position includes accountability for providing technical oversight of GMP manufacturing campaigns with CDMOs, reviewing and approving GMP documentation, and analyzing/presenting manufacturing data to support decision-making. This individual will serve as the lead investigator for deviations, own associated change controls, and contribute to regulatory filings. In addition, the role will support cross-functional teams in defining and implementing process control strategies, represent CTTO on internal strategy teams, and drive business-critical initiatives that enable product advancement and supply reliability. Travel of approximately 10-20% is expected.

Requirements

• B.S. or M.S. in Chemical Engineering, Bioengineering, Biotechnology, or related field with 4-8 years of relevant experience in process development or commercial manufacturing, or Ph.D. with a minimum of 2 years of relevant experience.
• Demonstrated ability to effectively work in cross-functional teams, meet deadlines, and manage multiple projects.
• Experience with leading deviation investigations and owning change controls.
• Experience providing technical support in clinical or commercial GMP environments.
• Strong knowledge of cGMP, ICH guidelines, PPQ (process validation), and control strategy development.
• Experience authoring, reviewing, and approving GMP documentation.
• Familiarity with disposable technologies such as single-use bioreactors (SUBs) and mixers (SUMs).
• Experience with data analysis tools (e.g., R, SAS) and root-cause analysis methodologies.
• Strong communication and presentation skills, with the ability to clearly explain complex technical concepts to cross-functional stakeholders.

Nice To Haves

• Experience with process control strategies and Six Sigma principles.
• Knowledge of cellular immunology and/or vector manufacturing.
• Knowledge of lentiviral or adeno-associated virus (AAV) manufacturing.

Responsibilities

• Support process and technology transfers, change management, and technical process support for gene delivery and editing products.
• Serve as a technical Subject Matter Expert (SME) within CTTO and across cross-functional project teams.
• Author regulatory filing sections throughout the product lifecycle.
• Assess process capability and lead investigations through analysis of manufacturing process data.
• Own and lead deviation investigations and associated change controls.
• Provide technical oversight during technology transfer and GMP manufacturing campaigns with Contract Development and Manufacturing Organizations (CDMOs).
• Review and approve GMP manufacturing documentation as required.
• Analyze and present manufacturing data to internal and external stakeholders to drive decision-making.
• Lead cross-functional teams in defining and implementing process control strategies.
• Support the commercialization and lifecycle management of viral vector products.
• Represent CTTO as the technical lead on internal strategy and governance teams.

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 including 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.
• Tuition reimbursement and a recognition program.

What This Job Offers

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