MES Project Manager | GMP/GxP Compliance & Ops Delivery

Cognizant Life Sciences Manufacturing; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

Cognizant Life Sciences Manufacturing is seeking 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.

You will own end-to-end project plans, governance, and stakeholder engagement, ensuring GMP/GxP compliance and alignment with 21 CFR Part 11 while coordinating across IT, operations, and vendors to deliver robust MES solutions.

Qualifications

• Degree in Computer Science, Engineering, Life Sciences, or a related discipline.
• 5+ years leading project delivery, ideally in life sciences.
• Experience delivering MES projects and knowledge of GMP/GxP.
• Experience with Agile, Waterfall, or hybrid delivery methods.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Skills

Project delivery leadership

GMP/GxP compliance

Agile/Waterfall/Hybrid delivery

Stakeholder engagement

Education

Degree in Computer Science, Engineering, Life Sciences, or related

Tools

Emerson Syncade

Körber PAS-X

Rockwell PharmaSuite

Siemens Opcenter

Job description

Cognizant Life Sciences Manufacturing is seeking 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.

You will own end-to-end project plans, governance, and stakeholder engagement, ensuring GMP/GxP compliance and alignment with 21 CFR Part 11 while coordinating across IT, operations, and vendors to deliver robust MES solutions.