Senior Engineer, MES
Core
Senior technical individual contributor leading MES electronic batch record (EBR) recipe authoring and logic design for GMP Cell Therapy manufacturing operations.
Role type
Senior IC MES Tech Lead (Recipe Authoring)
Builds
MES recipes and electronic batch records for commercial Cell Therapy manufacturing
Domain
Life Sciences / Cell Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
MES recipe authoring, EBR workflow design, parameterization, equipment interaction logic, exception handling, complex logic design, GMP compliance, 21 CFR Part 11, validation strategies (IQ/OQ/UAT), root cause analysis, change control, impact assessment
Preferred skills
Cross-functional collaboration with Manufacturing/MSAT/Quality, tech transfer support, process standardization, site/network forum contribution
Technologies
MES systems, Electronic Batch Records (EBR), GMP-compliant manufacturing environments
Responsibilities
Lead design and implementation of complex, high-risk, or non-standard MES recipes; Review and provide technical approval for recipe designs and configurations; Ensure compliance with GMP, data integrity, and 21 CFR Part 11; Serve as L3 technical escalation point for recipe-related MES issues; Perform advanced troubleshooting and root cause analysis of recipe logic; Define and maintain recipe authoring standards, patterns, and best practices
Seniority
Senior, hands-on IC
