Project Manager TPM6069

Tandem Project Management Ltd.; Munster; On-site; EUR 85,000 - 110,000; Full time

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

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 <61>, <62>, <71>, <85>; 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.