Project Manager – Microbiology & Sterilization Centre of Excellence

About the role

R&D Partners is seeking an experienced Project Manager to lead the creation of a state‑of‑the‑art Microbiology & Sterilization Centre of Excellence. You will be responsible for designing, equipping, qualifying, and preparing the facility for regulatory audits, ensuring it supports the medical device and combination product portfolio.

Key responsibilities

• Develop and maintain the overall project plan, including timelines, budgets, resources, and risk registers.
• Oversee laboratory space design and the installation, qualification, and validation of equipment such as isolators, incubators, and monitoring systems.
• Coordinate method transfer and validation for microbiology and sterilization testing (bioburden, endotoxin, microbial identification, sterility).
• Collaborate with Quality, Engineering, Procurement, and HR teams to ensure seamless project execution.
• Prepare the facility for regulatory inspections and audits.
• Recruit and onboard technical staff for the new centre.

Required profile

• Background in Microbiology, Biology, Biochemistry, Life Sciences, Engineering or a related discipline.
• Proven experience managing projects in regulated industries such as medical devices, pharmaceuticals or biologics.
• Strong leadership, communication and problem‑solving abilities.
• Ability to manage budgets, vendors and complex multi‑disciplinary projects.

Required skills

• Knowledge of GMP, ISO 13485 and FDA 21 CFR Part 820 regulatory standards.
• Familiarity with microbiology and sterilization testing processes (bioburden, endotoxin, microbial identification, sterility testing).
• Project management certification (e.g., PMP or PRINCE2) – preferred.
• Experience with laboratory setup, equipment qualification and method transfer – preferred.