Lead Microbiologist
On-siteDeeside, Wales, United Kingdom
Job Summary
Lead microbiological testing for facilities, processes, personnel, materials, and products in line with cGMP and procedural requirements at the Deeside site. Provide technical leadership for sterilisation activities, including validation test methods for terminally sterilised products, and manage out-of-specification investigations with laboratory reports. Collect and trend data to report findings, maintain laboratory metrics, and ensure compliance with Notified Bodies, GMP, and EHS regulations. Perform environmental and routine product monitoring, conduct method validations, and maintain operational equipment in a validated state. Coach and mentor laboratory technicians while seeking continuous improvement opportunities across the site. Occasional travel to the Rhymney site is required.
Required Qualifications
- 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
- Educated to degree level, or equivalent, within a Microbiological discipline
- Position involves occasional travel to our Rhymney site
- Full-time on-site at our Deeside site
- Opportunity for hybrid working (up to 1–2 days per week from home) for the right candidate
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