Role Summary
We are establishing a new Microbiology & Sterilization Centre of Expertise (CoE) to consolidate and strengthen our capabilities in bioburden testing, bacterial endotoxin testing (BET/LAL), microbial identification, and sterility testing in support of our medical device and combination product portfolio. We are seeking an experienced Project Manager to lead the end-to-end set-up of this centre - from facility design input and equipment qualification through method transfer, staffing, and operational go-live.
The successful candidate will combine deep technical familiarity with microbiology and sterilization testing environments with strong project leadership, decisiveness, and a bias for action. This individual will be the single point of accountability for delivering the CoE on time, on budget, and in a validated, audit-ready state.
Key Responsibilities
Project Leadership & Delivery
- 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.
Technical Scope - Microbiology & Sterilization Testing
- Lead 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.
Quality, Compliance & Validation
- 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 body, and regulatory agency audits.
Stakeholder & Team Management
- 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.
Risk, Issue & Change Management
- 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.
- Anticipate downstream implications of decisions and surface trade-offs transparently to decision-makers.
Required 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.
- 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.
Preferred Qualifications
- Prior experience setting up or transferring a microbiology laboratory or sterility assurance function.
- Familiarity with sterilization modalities (EO, gamma, e-beam, steam, VHP) and their associated microbiological controls.
- Experience supporting regulatory inspections (FDA, notified body, MHRA, HPRA) in a lab or sterility assurance context.
- Lean / Six Sigma or operational excellence exposure.
Behaviours & Ways of Working
- Works with speed and decisiveness - makes timely, well-reasoned decisions even under incomplete information, and adjusts as new data emerges.
- Escalates early and solves, not just surfaces - brings options and a recommendation, never just problems.
- Collaborates effectively across technical, quality, and commercial functions, adapting style to the audience.
- Communicates clearly, concisely, and honestly - comfortable challenging assumptions and being challenged.
- Takes ownership end-to-end; keeps commitments and holds others to the same standard.
- Resilient and composed under pressure; maintains momentum through ambiguity and change.
