Sterility Assurance Consultant (6 months+)

EPM Scientific; Leiden; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

EPM Scientific is supporting a client in the Netherlands seeking an experienced Sterility Assurance and Contamination Control Consultant for a 6+ month, site-based engagement on manufacturing operations. You will lead sterility assurance activities and collaborate with quality, manufacturing and validation teams to strengthen GMP practices.

The role requires on-site presence in the Netherlands and strong microbiology expertise.

Qualifications

• Proven experience in sterility assurance and contamination control.
• Strong microbiology background in regulated life sciences.
• Understanding of GMP and aseptic manufacturing principles.
• Experience in pharma/biotech/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.

Responsabilités

• 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.

Connaissances

Sterility assurance

Contamination control

Microbiology

GMP manufacturing

Stakeholder management

Communication skills

On-site work

Dutch language (advantage)

Description du poste

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.

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.