MES Project Manager

Summary:
We are seeking a senior, high-impact Project Manager to lead complex, multi-site MES transformation programs across a GxP-regulated pharmaceutical manufacturing network.This role is accountable for end-to-end delivery of MES platforms (e.g., Client-X, Pharma Suite, OpsCenter) including deployment, integration, validation (CSV), and operationalization at scale. The Project Manager operates with full ownership of scope, financials, governance, and regulatory readiness, ensuring all deliverables meet inspection-ready standards (GMP, GxP, 21 CFR Part 11, data integrity).

Roles & Responsibilities:

• Lead end-to-end MES transformation programs across multiple pharmaceutical manufacturing sites, from strategy and design through deployment, validation, go-live, and operationalization.
• Own overall program scope, schedule, budget, resources, risks, dependencies, and delivery governance for large-scale MES initiatives.
• Manage full-cycle implementation of MES platforms such as Werum Client-X, Ko rber PharmaSuite, Siemens Opcenter, or equivalent pharmaceutical MES solutions.
• Lead CSV/CSA activities and ensure validation deliverables including VP, URS, FS/DS, IQ/OQ/PQ, RTM, test scripts, deviations, and validation summary reports are completed on schedule.
• Ensure MES solutions comply with GMP/GxP, 21 CFR Part 11, data integrity, electronic records/signatures, and regulatory requirements.
• Direct complex IT/OT integrations between MES and systems such as ERP, LIMS, SCADA, DCS, PLC, historians, serialization, and laboratory systems.
• Provide executive-level leadership across Manufacturing, Quality, Validation, IT, Engineering, Automation, and external vendors/system integrators.