Lead Microbiologist

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 ConvaTec's mission, values, and quality standards.,

• Ensure facilities, processes, personnel, materials and products are microbiologically tested in line with cGMP and procedural requirements
• Provide microbiological support to Operations
• Manage out-of-specification (OOS), facilitate laboratory investigation reports and involve the laboratory manager where applicable.
• Collect and trend data, react to trends and report findings to manager
• Maintain laboratory metrics
• Ensure compliance is maintained as directed by Notified Bodies regulations
• Maintain compliance with GMP and EHS requirements and uphold these standards.
• Perform environmental monitoring and routine product monitoring; bioburden, VDmax25
• Seek and deliver continuous improvement opportunities across the site
• Perform method validations
• Adhere to legal, corporate and site legislation
• Maintain validation of Microbiology test methods
• Ensure maintenance of the operational equipment within the lab.
• Maintain operational equipment within a validated state
  
  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 (specification and procedural based).
• Ability to work effectively in a fast-paced environment, embracing change and proactively leading initiatives that improve team performance, ways of working, and the overall working environments.
• Knowledge of relevant ISO standards (e.g., ISO 11737, ISO 11137, ISO 11135, ISO 17665), pharmacopoeia references, and FDA regulations.
• Knowledge of continuous improvement and quality assurance methods and techniques.
• Coaching and mentoring of laboratory technicians.
Qualifications/Education:
• Educated to degree level, or equivalent, within a Microbiological discipline.
  
  Hybrid working model (1-2 days per week) at our Deeside location.