MES Engineer IT Systems
Core
Product Owner for the Manufacturing Execution System (MES) supporting Breyanzi (CAR T cell therapy) manufacturing, translating process requirements into compliant electronic batch records (EBRs) and leading Agile delivery.
Role type
Senior Product Owner (MES) / Agile Sprint Manager
Builds
Electronic Batch Records (EBRs) and MES workflows for cell therapy manufacturing
Domain
Biopharmaceuticals / Cell Therapy Manufacturing / GMP Compliance
Required skills
MES (Syncade), GMP compliance, Computer System Validation (CSV), Agile sprint management, CAPA management, stakeholder management, technical writing, change control
Preferred skills
eMES development, commercial CAR T cell therapy manufacturing, 21 CFR Part 11, GAMP 5, data integrity
Technologies
Syncade, Jira, ServiceNow
Responsibilities
Own the MES product backlog and roadmap; translate manufacturing requirements into functional specifications and test cases; lead Agile sprints and sprint planning; manage production deviations and CAPA actions; maintain validated state of the system via change control; train and mentor junior/offshore engineers.
Seniority
Senior, hands-on IC with team leadership
