Senior MES Engineer (m/f/d)
Core
Implementing and supporting Manufacturing Execution Systems (MES) for biologics drug substance manufacturing, ensuring technical alignment between early-stage pipeline facilities and commercial supply.
Role type
Senior IC MES Engineer (PAS-X)
Builds
Validated MES solutions and electronic batch records for biologics production
Domain
Biopharmaceuticals / Manufacturing Execution Systems
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
PAS-X system expertise, GMP compliance, Change Control management, Data Integrity (ALCOA+), SDLC requirements, Technical Leadership, Problem-Solving, Documentation standards
Preferred skills
Master Recipe Management, GMBR/MBR design, Weigh & Dispense, eRec/eSig, Commissioning and validation
Technologies
PAS-X, DeltaV
Responsibilities
Integrate PAS-X with site automation layer (DeltaV), maintain and develop MES GMBRs, support tech transfer to GMP status, perform change controls, ensure ALCOA+ data integrity, conduct MES training, support regulatory inspections
Seniority
Senior, hands-on IC
