MES Engineer IT Systems

Bristol Myers Squibb • Bothell, WA

1d

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 role also manages Agile delivery for the Breyanzi book of work in Jira, reports project status to stakeholders, and owns production deviations and CAPAs related to Breyanzi. It provides primary application support and participates in an on-call rotation for L2 escalations. The position requires hands-on MES experience, preferably Syncade, and responsibility for GMP-regulated documentation, validation, change control, and quality compliance.

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 and GMP procedure writing skills.
• 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 in alignment 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.
• Translate process requirements into complete MES electronic batch records that comply with GMP, regulatory expectations, 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.
• Prepare 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 team members.
• Review developers’ design, configuration, and test work, and provide guidance on quality, optimization, and EBR and MES recipe/workflow enhancements.
• Train and onboard engineers on the Breyanzi manufacturing process and MES build standards.
• Address production deviations and CAPA actions related to Breyanzi MES, including investigation, root cause analysis, corrective and preventive actions, and effectiveness checks.
• Provide primary application support for Breyanzi MES and participate in the on-call rotation for L2 production escalations.
• Maintain the validated state of the system through change control, including creating changes in ServiceNow, 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

• Potential eligibility for discretionary incentive cash and stock opportunities.
• Comprehensive benefit plans that may include wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval, and 11 paid company holidays each year.
• For specified employee groups, 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 of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year’s Day.

What This Job Offers

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