Sterility Assurance Consultant (6 months+)

Leiden

Contract

Negotiable

Quality

CR/611884_1790412622

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.

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