About the Company
Role Summary We're looking for an MES Project Manager to drive delivery of Manufacturing Execution System projects across our client’s API manufacturing operations — from initial implementation through ongoing enhancement and support.
About the Role
We're looking for an MES Project Manager to drive delivery of Manufacturing Execution System projects across our client’s API manufacturing operations — from initial implementation through ongoing enhancement and support.
Responsibilities
- Delivery & Planning
- Own end-to-end delivery of SynCade (DeltaV MES) projects — scope, schedule, and budget — building and maintaining project plans, risk registers, and resourcing strategies as the program evolves.
- Bring project governance into line with GxP, FDA 21 CFR Part 11, and other applicable regulatory frameworks from the outset, not as a later compliance check.
- Coordinate delivery across business stakeholders, internal IT, vendors, and system integrators, keeping dependencies visible and on track.
- Stakeholder Engagement & Change
- Serve as the primary bridge between IT, operations, and regulatory/quality functions throughout the project lifecycle.
- Run workshops and structured discussions to capture business requirements and shape system enhancements collaboratively.
- Lead training and change management activity so MES adoption on the floor is smooth rather than forced.
- MES Design, Build & Integration
- Oversee the full MES lifecycle — design, configuration, testing, validation, and deployment.
- Partner closely with automation, quality, and IT to deliver clean integration with DCS ad and adjacent systems.
- Compliance & Documentation
- Ensure every MES deliverable holds up against GMP, GxP, FDA 21 CFR Part 11 requirements.
- Work hand-in-hand with Quality Assurance on system validation and audit readiness.
- Keep project documentation current and structured to withstand regulatory scrutiny.
Qualifications
- Degree in Computer Science, Engineering, Life Sciences, or a related discipline.
Required Skills
- 5+ years proven track record leading project delivery, ideally within life sciences, with a strong record of hitting scope, schedule, and budget targets — MES delivery experience a strong plus.
- Solid grounding in GMP, GxP, and the compliance landscape that governs regulated manufacturing IT.
- Comfortable running delivery under Agile, Waterfall, or hybrid methodologies, depending on what the Programme demands.
Preferred Skills
- Exposure to MES platforms such as Emerson Syncade, Körber PAS-X, Rockwell PharmaSuite, or Siemens Opcenter.
- MES-to-DCS integration experience is a strong advantage.