MES Change Specialist
Core
Design, build, test, validate, and maintain electronic documentation and Manufacturing Execution Systems (MES) for pharmaceutical production and packaging.
Role type
Senior IC MES Change Specialist
Builds
Electronic documentation, MES modifications, and validated production processes for commercial and pipeline drug products.
Domain
Pharmaceutical manufacturing (sterile/finished goods) + Computerized Systems Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
MES/electronic batch record system experience, CSV (computerized systems validation), change management system ownership, test script writing and execution, deviation management, project schedule monitoring, regulatory compliance knowledge, automation system knowledge (SAP, PLC, HMI), sterile pharmaceutical manufacturing experience
Preferred skills
Rockwell systems troubleshooting, EBR/MES deployment project experience
Technologies
Veeva, Trackwise, SAP, PLC, HMI, Rockwell systems
Responsibilities
Troubleshoot mechanical or automation failures, identify efficiency improvements via data analytics, lead user requirement gathering for MES modifications, define requirements and execute test scripts for CSV functions, plan and execute MES change reviews, monitor project schedules, draft test plans for new recipes, manage high-complexity MES deviations, support site initiatives (tech transfers, launches), provide audit support and regulatory finding closure
Seniority
Mid-Senior, hands-on IC
