Project Manager TPM6069

Summary:

A Medical Devices company based in Clare is looking for a Project Manager to lead the end-to-end set-up of their new Microbiology & Sterilization Centre of Expertise (CoE), from facility design input and equipment qualification through method transfer, staffing, and operational go-live. The incumbent will be the single point of accountability for delivering the CoE on time, on budget, and in a validated, audit-ready state.

Responsibilities:

• Own the end-to-end project plan for the CoE set-up, including scope, schedule, budget, resources, risks, and deliverables.
• Drive the project with speed and decisiveness; proactively identify critical path activities and remove blockers before they impact delivery.
• Escalate issues early and constructively, always accompanied by clearly framed options and a recommended solution.
• Maintain transparent, data-driven reporting to steering committees, sponsors, and cross-functional stakeholders.
• Microbiology & Sterilization TestingLead the design, build, and commissioning of controlled laboratory environments suitable for bioburden, bacterial endotoxin, microbial identification, and sterility testing.
• Coordinate specification, procurement, installation, and qualification (IQ/OQ/PQ) of laboratory equipment (e.g., isolators, incubators, autoclaves, LAL readers, MALDI-TOF or equivalent ID platforms, environmental monitoring systems).
• Oversee method transfer and method validation activities in alignment with applicable compendial and regulatory expectations (e.g., USP ; Ph. Eur. equivalents; ISO 11737-1/-2; ISO 14644; ISO 11137/11135 as relevant).
• Partner with Sterility Assurance, Quality, and Operations to integrate the CoE into the broader sterilization lifecycle and product release strategy.
• Ensure all CoE activities are executed in compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and applicable data integrity (ALCOA+) expectations.
• Drive generation and approval of user requirements, validation master plan, risk assessments, SOPs, and training documentation.
• Support inspection/audit readiness from day one, including preparation for internal, notified
• Build strong, collaborative relationships across Quality, Microbiology, Sterility Assurance, Engineering, Facilities, Procurement, IT, HR, and external vendors.
• Lead a cross-functional core team through a matrix structure; set clear expectations, hold the team accountable, and recognise contributions.
• Coordinate recruitment and onboarding of CoE technical staff in partnership with the functional hiring manager and HR.
• Maintain a live risk and issue register; drive mitigation actions to closure with clear ownership and due dates.
• Manage scope and change control rigorously, ensuring all changes are assessed for cost, schedule, quality, and compliance impact.

Qualifications & Experience:

• Bachelor's degree in Microbiology, Biology, Biochemistry, Life Sciences, Engineering, or a related technical discipline. Advanced degree preferred.
• Minimum 5-7 years of project management experience in a regulated life sciences environment (medical devices, pharmaceuticals, or biologics).
• Demonstrated experience delivering projects involving microbiology laboratories and/or sterility assurance - e.g., new lab set-up, lab expansion, method transfer, or equipment qualification would be preferred.
• Working knowledge of bioburden, bacterial endotoxin (LAL), microbial identification, and sterility testing workflows, including associated compendial methods and regulatory expectations.
• Strong understanding of GMP, ISO 13485, 21 CFR Part 820, and computer systems validation / data integrity principles.
• Proven ability to manage budgets, vendors, and CAPEX-intensive projects through to qualification and operational handover.

PMP, PRINCE2, or equivalent project management certification preferred.