MES Project Manager

Cognizant Life Sciences Manufacturing

Cork

On-site

EUR 90,000 - 120,000

Full time

11 days ago
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Job summary

Cognizant Life Sciences Manufacturing is seeking an experienced MES Project Manager to drive delivery of Manufacturing Execution System projects across our API manufacturing operations—from initial implementation through ongoing enhancements and support.

The role requires coordinating across IT, operations, quality/regulatory functions and vendors to ensure on-time, within-budget delivery while maintaining full GMP/GxP compliance. Familiarity with DeltaV MES or similar platforms is a plus.

Qualifications

  • Degree in computer science, engineering, life sciences, or related field.
  • 5+ years leading project delivery in life sciences or regulated manufacturing IT.
  • Knowledge of GMP, GxP, and FDA 21 CFR Part 11 compliance.
  • Experience with Agile, Waterfall, or hybrid delivery methodologies.

Responsibilities

  • Own end-to-end MES project delivery from scope to deployment.
  • Govern projects with risk registers, plans, and governance.
  • Coordinate across IT, operations, and regulatory/quality functions.
  • Lead change management and training for MES adoption.
  • Ensure alignment with GMP, GxP and 21 CFR Part 11 requirements.
  • Maintain documentation to withstand regulatory scrutiny.

Skills

Project management
Regulatory compliance
Agile/Hybrid

Education

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

Tools

Emerson Syncade
Körber PAS-X
Rockwell PharmaSuite
Siemens Opcenter

Job description

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.
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