MES Engineer IT Systems

Bristol Myers Squibb • Bothell, WA

2d • $108,650 - $131,655

About The Position

The MES Product Owner for Breyanzi is accountable for the end-to-end Manufacturing Execution System (MES) solution supporting the Breyanzi CAR T cell therapy manufacturing process at BMS in Bothell. The role serves as the process and product expert, translating Manufacturing, Quality, and Supply Chain requirements into buildable specifications for MES engineers and leading a sub-team that includes junior and offshore engineers. It ensures electronic batch records (EBRs) are compliant, efficient, and inspection-ready.

The position leads Agile delivery for the Breyanzi book of work in Jira, manages project status and stakeholder reporting, supports production operations, and owns Breyanzi-related deviations and CAPAs. It also provides primary application support and participates in the on-call rotation for L2 escalations. The role maintains GMP-compliant documentation and procedures, validated system state, and compliance with quality and regulatory standards. Hands-on MES experience, preferably with Syncade, and expertise in Computer System Validation are required; Breyanzi process knowledge and eMES development experience are advantageous.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field, or equivalent experience.
• At least 5 years of relevant industry experience in biopharmaceutical or cell therapy manufacturing and/or manufacturing IT systems.
• Strong working knowledge of the Breyanzi manufacturing process or a comparable autologous cell therapy process.
• Hands-on experience with Manufacturing Execution Systems, preferably Syncade, including EBR design and build.
• Experience leading or mentoring engineers, including offshore or junior team members, and translating business requirements into technical specifications.
• Experience managing production deviations, investigations, and CAPAs in a GMP environment.
• Experience with electronic document management and quality management systems, change control, and CSV/validation practices in regulated industries.
• Technical writing competency, including GMP procedure writing.
• Strong communication, collaboration, and stakeholder management skills.
• Willingness to participate in an on-call rotation for L2 production support.

Nice To Haves

• Prior experience developing in eMES.
• Prior experience supporting commercial CAR T cell therapy manufacturing.
• Experience with 21 CFR Part 11, GAMP 5, and data integrity requirements.

Responsibilities

• Own the Breyanzi MES product backlog, prioritize enhancements and fixes, and maintain the roadmap with Manufacturing, Quality, Supply Chain, Facilities, and Tech Transfer stakeholders.
• Serve as the Breyanzi MES process subject matter expert; capture and document requirements and translate them into user requirements, functional and design specifications, and test cases.
• Ensure process requirements are translated into complete MES EBRs that meet GMP compliance and regulatory expectations, including 21 CFR Part 11 and data integrity principles.
• Lead Agile sprints in Jira, including sprint planning, backlog grooming, user story review and approval, sprint reviews, and retrospectives.
• Maintain the project plan, milestones, timelines, dependencies, risks, and issues as scope and priorities change.
• Create and publish project scorecards and status reports for IT and business leadership, covering milestones, risks, and delivery health.
• Lead the Breyanzi MES sub-team, assign work, set expectations, and track delivery, including for offshore and early-career resources.
• Review developers’ design, configuration, and test work and provide guidance on quality, optimizations, and EBR and MES recipe/workflow enhancements.
• Train and onboard engineers on the Breyanzi manufacturing process and MES build standards.
• Address Breyanzi MES production deviations and CAPA actions, including investigations, root cause analysis, corrective and preventive implementation, and effectiveness checks.
• Provide primary application support for Breyanzi MES and participate in the on-call rotation for L2 production escalations.
• Maintain the system’s validated state through change control, including creating ServiceNow changes, obtaining pre-approval, executing and deploying changes, attaching evidence, closing tasks, and obtaining post-approval.
• Participate in GMP validation activities, including developing and executing IQ/OQ/PQ testing, and support software releases, audits, and inspections.
• Identify and drive process and system improvements, standardization, and reuse across Breyanzi EBRs and other manufacturing systems.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• U.S.-based exempt employees are eligible for Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays annually.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level