Lead Microbiologist

Overview

The Lead Microbiologist acts as the Site Microbiology Expert for the Deeside and Rhymney sites, providing technical leadership for microbiology and sterilisation activities. The role is responsible for leading a small laboratory team, ensuring compliance with regulatory, quality, and procedural requirements, and overseeing sterilisation validation test methods for terminally sterilised products manufactured at the Deeside site. The position supports continuous improvement, maintains compliance within controlled environments, and champions Conva Tec's mission, values, and quality standards.

• Provide microbiological support to Operations and ensure facilities, processes, personnel, materials and products are microbiologically tested in line with cGMP and procedural requirements.
• Lead a laboratory team, manage day-to-day activities, and drive continuous improvement opportunities across the site.
• Manage out-of-specification (OOS) events, facilitate laboratory investigation reports, and involve the laboratory manager where applicable.
• Collect, trend, and report data and maintain laboratory metrics; react to trends and communicate findings to management.
• Maintain compliance with GMP, EHS requirements and Notified Bodies regulations where applicable.
• Perform environmental monitoring and routine product monitoring (bioburden, VDmax
  25) and ensure methods are validated and maintained.
• Oversee sterilisation validation test methods for terminally sterilised products and maintain validation of microbiology test methods.
• Ensure maintenance of laboratory operational equipment and keep it in a validated state.
• Support QA through documentation, technical reports, specifications, and procedural updates; work within a Quality Management System (QMS).
• Apply knowledge of relevant ISO standards (e.g., ISO 11737, ISO 11137, ISO 11135, ISO 17665), pharmacopoeia references, and FDA regulations.
• Collaborate with cross-functional teams and coach/mentor laboratory technicians.

• Demonstrated experience in microbiology within a regulated manufacturing environment.
• Practical experience working within a Quality Management System (QMS) in a complex and regulated manufacturing environment.
• Understanding of GMP requirements within a regulated environment.
• Exposure to data management and interpretation of data sets; excellent written communication skills with experience authoring technical reports and quality documentation (specifications and procedures).
• Ability to work effectively in a fast-paced environment, embrace change, and proactively lead initiatives to improve team performance and working practices.
• Knowledge of continuous improvement and quality assurance methods and techniques.
• Coaching and mentoring of laboratory technicians.
• Education:
  
  Degree level (or equivalent) in Microbiology or a related discipline.
• Hybrid working model (1-2 days per week) at the Deeside location.