Staff Scientist – Microbiology,Sterility Assurance Job Lancashire area,England UK,Quality Assurance

Supporting end‑to‑end Microbiological Quality & Sterility Assurance (MQ&SA) activities related to suppliers and external manufacturing processes
Contributing to change requests and projects impacting controlled environments, cleaning, and sterilization processes
Supporting contamination control strategies, including environmental monitoring and investigation activities
Providing technical guidance and training on microbiological quality and sterility assurance
Acting as subject matter expert for investigations, CAPA, non‑conformances, audit observations, and risk assessments
Supporting due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA expertise and risk input
Supporting development and updates of supplier quality agreements
Coordinating and participating in supplier audits, including preparation, on‑site support, response review, and follow‑up activities
Partnering with cross‑functional teams to support supplier qualification and lifecycle management
Contributing to remediation activities following audits or regulatory findings
Building strong relationships with external partners, including manufacturers, suppliers, sterilization providers, and testing laboratories
Coaching and supporting colleagues and partners in MQ&SA practices

Requirements

Bachelor’s degree in Microbiology, Biological Sciences, Engineering, or a related field
At least 6 years of experience in microbiology and sterilization assurance within the medical device or pharmaceutical industry
Strong knowledge of microbiological control, contamination control, and sterilization processes
Familiarity with applicable standards and regulations (e.g., ISO, EN, AAMI)
Experience conducting or supporting investigations, test method development, and validation
Knowledge of regulatory and quality requirements related to suppliers and external manufacturing
Experience supporting audits, inspections, or compliance assessments
Strong communication and collaboration skills, with the ability to work across functions and levels
Ability to work independently while contributing effectively to team objectives
Fluent in English (French and/or German are a plus)
Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity.

Hard Skills

Soft Skills

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Staff Scientist – Microbiology, Sterility Assurance