CoE Project Lead: Microbiology & Sterilization

Tandem Project Management Ltd.

Munster

On-site

EUR 85,000 - 110,000

Full time

6 days ago
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Job summary

Tandem Project Management Ltd. is seeking a Project Manager in Ireland to lead the end-to-end set-up of a new Microbiology & Sterilization Centre of Expertise in Clare.

You will oversee design input, equipment qualification, method transfer, staffing, and go-live to ensure an audit-ready, on-time, on-budget delivery. The role requires 5–7 years of PM experience in regulated life sciences, strong GMP/ISO knowledge, and collaboration across Quality, Sterility, Engineering, and Facilities.

Qualifications

  • Bachelor’s degree in Microbiology or related science; advanced degree preferred.
  • 5–7+ years of PM experience in regulated life sciences.
  • Experience delivering microbiology labs and/or sterility projects.
  • Knowledge of GMP, ISO 13485, 21 CFR Part 820, and data integrity.
  • PMP, PRINCE2, or equivalent certification preferred.

Responsibilities

  • Own end-to-end CoE set-up plan: scope, schedule, budget, resources.
  • Drive project speed, identify critical path, remove blockers.
  • Maintain data-driven reporting to steering committees and stakeholders.
  • Lead design, build, and commissioning of lab environments for testing.
  • Coordinate IQ/OQ/PQ of laboratory equipment.
  • Oversee method transfer and validation aligned with regulatory expectations.
  • Integrate CoE into the sterilization lifecycle with QA, Sterility, Engineering.
  • Support inspections and audit readiness from day one.

Skills

Project management
Budget management
Vendor management
Regulatory compliance
Stakeholder management
Cross-functional collaboration

Education

Bachelor’s degree in Microbiology / Life Sciences
Advanced degree preferred

Job description

Tandem Project Management Ltd. is seeking a Project Manager in Ireland to lead the end-to-end set-up of a new Microbiology & Sterilization Centre of Expertise in Clare.

You will oversee design input, equipment qualification, method transfer, staffing, and go-live to ensure an audit-ready, on-time, on-budget delivery. The role requires 5–7 years of PM experience in regulated life sciences, strong GMP/ISO knowledge, and collaboration across Quality, Sterility, Engineering, and Facilities.

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