Operational Technology MES Engineer
Core
System Owner for PharmaSuite MES and AVEVA PI data platforms, digitizing paper-based processes and ensuring compliance in pharma manufacturing.
Role type
Operational Technology MES Engineer (System Owner)
Builds
Digital manufacturing capabilities including Electronic Batch Records, Equipment Workflows, and shop floor data strategies.
Domain
Life Sciences / Pharmaceutical Manufacturing / IT Operations
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
MES implementation (PharmaSuite or similar), GAMP 5 and 21 CFR Part 11 compliance, system lifecycle management, data mapping, functional process design, vendor management, change management
Preferred skills
Master's degree in IT/CS, experience with ERP/MES/CMMS integration, analytics for manufacturing performance
Technologies
PharmaSuite, AVEVA PI, Microsoft Office Suite
Responsibilities
Act as System Owner for MES and data platforms, partner with Manufacturing/Quality to digitize processes, define shop floor data strategy, ensure regulatory compliance, manage system upgrades and obsolescence, lead implementation of eBR and electronic logbooks, support deviation investigations and inspections, drive training and adoption, manage system vendors and integrators
Seniority
Mid-Senior, hands-on IC with project leadership