MES Project Manager (DBR)

Job Summary

MES Project Manager (DBR) - The MES Project Manager leads the planning delivery and deployment of Manufacturing Execution System (MES) projects across life science manufacturing sites. The role manages scope budget timelines and risks while coordinating Manufacturing Quality IT Automation and vendors to ensure solutions are delivered on time validated per GAMP 5 and compliant with GxP and 21 CFR Part 11 requirements.

Responsibilities

• Lead end-to-end MES projects (e.g. Syncade PAS-X PharmaSuite) from initiation through design build validation go-live and hypercare
• Define project scope schedule budget and resource plans and track progress against milestones and KPIs
• Manage risks issues dependencies and change requests escalating to senior leadership and steering committees as needed
• Coordinate cross-functional teams across Manufacturing QA IT Automation and Process Engineering to gather and prioritize requirements
• Oversee system integration with ERP LIMS DeltaV/SCADA historians and equipment to ensure seamless data flow
• Ensure CSV deliverables are completed per GAMP 5 including validation plans test protocols and summary reports in compliance with GxP and data integrity requirements
• Manage vendors system integrators and contractors including contracts deliverables and performance
• Drive site rollouts and standardization through global templates change management and user training
• Provide regular status reporting and stakeholder communication to ensure alignment and transparency
• Capture lessons learned and support post-go-live stabilization handover to support teams and continuous improvement