Digital Manufacturing OT Lead, Technical Operations
Core
Lead digital manufacturing operations and MES implementation for pharmaceutical manufacturing, serving as the primary point of contact for PharmaSuite MES and AVEVA PI platforms.
Role type
Senior IC Manufacturing OT Lead (MES & Data Platforms)
Builds
Digital manufacturing capabilities, electronic batch records, and shop floor data strategies for pharmaceutical production.
Domain
Pharmaceutical manufacturing / Industrial IoT / Manufacturing Execution Systems
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Manufacturing Execution Systems (MES) implementation, AVEVA PI, GAMP 5, 21 CFR Part 11, GMP regulations, system lifecycle management, change control, vendor management, data mapping, functional process design, UAT testing.
Preferred skills
Upstream/Downstream/BAM manufacturing experience, ERP integration, analytics and metrics for performance improvement, capital project leadership.
Technologies
PharmaSuite MES, AVEVA PI, ERP, CMMS, Microsoft Office Suite
Responsibilities
Act as Operations lead during digital platform implementation and rollout; Define and drive shop floor data strategy; Ensure compliance with GAMP 5 and 21 CFR Part 11; Lead implementation of Electronic Batch Records and Equipment Workflows; Support deviation investigations and CAPAs; Drive training and change management for digital capabilities; Manage system vendors and integrators.
Seniority
Senior, hands-on IC with supervisory experience
