Sterility Assurance Senior Specialist – 9‑Month Contract in Reykjavik

About the role

Join a fast‑growing global biologics and biosimilars manufacturer as a Sterility Assurance Senior Specialist. This 9‑month contract position is based on site in Reykjavik and offers a unique opportunity to shape the contamination control strategy for a brand‑new drug substance suite.

Key responsibilities

• Lead and support the site’s contamination control strategy across drug substance and drug product manufacturing.
• Own environmental and personnel monitoring, including investigations, trending and reporting.
• Provide sterility assurance and microbiology expertise to ensure cGMP compliance.
• Author, review and approve GMP documentation; act as SME for deviations, CAPAs and change controls.
• Support regulatory and client audits and maintain inspection readiness.
• Lead disinfectant efficacy studies, oversee gowning and cleaning regimes, and plan aseptic process simulations.
• Coach and mentor less experienced team members.

Required profile

• 5–15+ years of experience in sterility assurance or microbiology within biopharmaceutical or biologics manufacturing.
• Bachelor’s degree with strong hands‑on experience (advanced degree equally valued).
• Practical experience in contamination control strategy and knowledge of facility design and GMP area qualification.
• Proven track record supporting regulatory inspections.
• EU/EEA or EFTA citizenship or existing right to work in Iceland.

Required skills

• Sterility assurance
• Microbiology
• Contamination control
• Environmental monitoring
• Personnel monitoring
• GMP documentation
• Deviation and CAPA management
• Regulatory inspection support
• Disinfectant efficacy testing
• Aseptic process simulation

What we offer

• Ground‑floor seat on a new drug substance suite.
• Potential path to a permanent role for the right candidate.
• Dynamic, fast‑moving environment with global impact.