Project Manager - Microbiology & Sterilization Centre of Expertise

About the Role

Join an innovative project pioneering advancements in laboratory capabilities by leading the setup of a cutting-edge Microbiology & Sterilization Centre of Expertise (CoE). This position involves managing all aspects of establishing a new facility including design, equipment installation and qualification, method transfer, regulatory compliance, and operational readiness to support transformative healthcare products in medical device and combination product sectors.

Key Responsibilities

• Create and control a comprehensive project plan addressing schedules, budgets, resource allocation, and risk management.
• Lead the design and establishment of laboratory environments tailored for microbiology and sterilization testing activities.
• Supervise the procurement, installation, and validation of laboratory equipment such as isolators, incubators, and monitoring devices.
• Ensure effective transfer and validation of analytical testing methods meeting industry regulations.
• Collaborate with cross-functional departments including Quality Assurance, Engineering, Procurement, and Human Resources to guarantee seamless project progression.
• Prepare the facility for regulatory inspections and compliance audits.
• Manage the recruitment and induction processes for technical personnel designated for the CoE.
• Identify, assess, and mitigate project risks, resolve issues, and handle scope changes proactively.

Essential Qualifications and Experience

• Academic background in Microbiology, Biology, Biochemistry, Life Sciences, Engineering, or closely related disciplines.
• Proven experience in project management within regulated fields such as medical devices, pharmaceuticals, or biologics manufacturing.
• Knowledge of microbiology and sterilization laboratory testing procedures, including bioburden, endotoxin analysis, microbial identification, and sterility assessments is advantageous.
• Familiarity with regulatory frameworks like Good Manufacturing Practice (GMP), ISO 13485, and FDA 21 CFR Part 820.
• Strong leadership aptitude coupled with excellent communication and analytical problem-solving skills.
• Demonstrated competency in managing financial budgets, vendor relations, and complex project deliverables.
• Project management certification such as PMP or PRINCE2 is desirable.
• Experience with laboratory build-outs, method transfer processes, and sterility assurance programs is preferred.

Additional Information

To be eligible for this position, candidates must have the legal right to work in Galway, Ireland. Recruitment, onboarding, and regulatory adherence are critical components of this role. For further inquiries, please contact the hiring coordinator directly.