Position 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 ConvaTec's mission, values, and quality standards.
Key Responsibilities:
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
Skills & Experience:
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:
Travel Requirements:
Working Conditions :
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About Convatec
Pioneering trusted medical solutions to improve the lives we touch:
Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.
