At a Glance
- Tasks: Support microbiological quality and sterility assurance activities in a dynamic environment.
- Company: Join a leading company in the medical device and pharmaceutical industry.
- Benefits: Competitive salary, professional development, and opportunities for career growth.
- Other info: Collaborate with cross-functional teams and build strong relationships with external partners.
- Why this job: Make a real impact on quality assurance and contamination control strategies.
- Qualifications: Bachelor's degree in Microbiology or related field with 6+ years of experience.
The predicted salary is between 55000 - 70000 £ per year.
- 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
- microbiological quality assurance
- sterility assurance
- contamination control
- environmental monitoring
- investigations
- CAPA
- non conformances
- audit observations
- risk assessmentstest method development
- Soft Skills
- communication
- collaboration
- independence
- coaching
- relationship building
- cross-functional teamwork
- technical guidance
- training
- problem-solving
- adaptability
We think you need these skills to ace Staff Scientist – Microbiology, Sterility Assurance
Microbiological Quality Assurance
Sterility Assurance
Contamination Control
Environmental Monitoring
Investigations
CAPA
Non Conformances
