Specialist, MSAT Manufacturing Systems Engineer
Core
Design, implement, and maintain Manufacturing Execution Systems (MES) and Electronic Batch Records (eBR) for cell therapy product manufacturing.
Role type
Manufacturing Systems Engineer (MES/eBR)
Builds
Digital manufacturing solutions for cell therapy production
Domain
Biopharmaceutical manufacturing (Cell Therapy)
Required skills
MES implementation, Electronic Batch Records (eBR), Computer System Validation (CSV), cGMP/GMP compliance, Data Integrity, Change Management, Process Automation, Root Cause Analysis, Stakeholder Management
Preferred skills
Emerson Syncade, DeltaV, Valgenesis, Veeva Vault, Trackwise, Cell culture, Cryopreservation, Aseptic processing, SCADA, LIMS
Technologies
MES, eBR, DeltaV, Emerson Syncade, Valgenesis, Veeva Vault, Trackwise, SCADA, LIMS, ERP
Responsibilities
Support MES recipe modifications and change controls, Gather user requirements for recipe development, Lead design and testing of Electronic Batch Records, Perform process monitoring and optimization, Interface with Manufacturing, Quality, and IT teams, Translate business requirements into functional specifications
Seniority
Mid-Senior, hands-on IC
