Sterility Assurance Consultant (6 months+)
Leiden
Contract
Negotiable
Quality
CR/611884_1790412622
Sterility Assurance Consultant (6 months+)
We are supporting a client in the Netherlands who is seeking an experienced Sterility Assurance and Contamination Control Consultant for an initial 6+ month engagement. This is a site-based position requiring regular presence on-site, supporting critical quality and microbiological activities within a regulated manufacturing environment.
The successful candidate will act as a key subject matter expert in sterility assurance, contamination control strategies, and microbiological processes, helping to ensure compliance, product quality, and operational excellence.
Responsibilities
- Lead and support sterility assurance activities across manufacturing operations
- Develop, review, and improve contamination control strategies
- Provide microbiological expertise to support quality and operational teams
- Assess aseptic processes and identify opportunities for improvement
- Support environmental monitoring programmes and trend analysis
- Assist with investigations, deviations, CAPAs, and risk assessments
- Ensure compliance with GMP regulations and industry best practice
- Collaborate with cross-functional teams on quality and manufacturing initiatives
- Support inspection readiness and regulatory activities where required
Requirements
- Proven experience in sterility assurance and contamination control
- Strong microbiology background within a regulated life sciences environment
- Understanding of GMP and aseptic manufacturing principles
- Experience within pharmaceutical, biotechnology, ATMP, or medical device industries
- Excellent stakeholder management and communication skills
- Ability to work on-site in the Netherlands
- Dutch language capability would be highly advantageous
Ideal Candidate Profile
An experienced Sterility Assurance or Microbiology professional with a strong background in contamination control and GMP manufacturing environments. The ideal consultant will be comfortable working on-site, acting as a technical SME, and partnering with quality, manufacturing, and validation teams to strengthen sterility assurance practices. Dutch-speaking candidates are particularly attractive for this opportunity.