Lead Microbiologist
Core
Lead microbiology and sterilisation activities for terminally sterilised medical products at Deeside and Rhymney sites, ensuring regulatory compliance and leading a small laboratory team.
Role type
Lead Microbiologist (Site Microbiology Expert)
Builds
Terminally sterilised medical products
Domain
Medical device manufacturing / Sterilisation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology in regulated manufacturing, Quality Management System (QMS), GMP compliance, Data management and interpretation, Technical report authoring, Method validation, Environmental monitoring, Bioburden testing, VDmax25 testing, ISO standards knowledge (11737, 11137, 11135, 17665), Pharmacopoeia references, FDA regulations, Continuous improvement methods, Coaching and mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Ensure facilities, processes, personnel, materials and products are microbiologically tested in line with cGMP and procedural requirements; Manage out-of-specification (OOS) and facilitate laboratory investigation reports; Collect and trend data, react to trends and report findings; Perform environmental monitoring and routine product monitoring; Perform method validations; Maintain validation of Microbiology test methods; Ensure maintenance of the operational equipment within the lab in a validated state; Provide microbiological support to Operations; Seek and deliver continuous improvement opportunities across the site.
Seniority
Senior, hands-on IC