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 / Sprint Manager
Builds
Compliant electronic batch records (EBRs) and MES workflows for cell therapy manufacturing
Domain
Biopharmaceuticals / Cell Therapy Manufacturing / GMP Compliance
Required skills
Manufacturing Execution Systems (MES) expertise, Computer System Validation (CSV), Agile sprint management, GMP compliance, CAPA management, Technical writing, Stakeholder management, Team leadership, Change control processes
Preferred skills
Syncade platform experience, CAR T cell therapy process knowledge, eMES development, 21 CFR Part 11 expertise, GAMP 5 knowledge
Technologies
Jira, ServiceNow, Syncade
Responsibilities
Own the MES product backlog and roadmap; Translate manufacturing requirements into functional specifications and test cases; Lead Agile sprints and manage project timelines; Mentor junior and offshore engineers; Manage production deviations and CAPA investigations; Execute change control and validation activities (IQ/OQ/PQ); Provide L2 application support.
Seniority
Senior, hands-on IC with team leadership
