Sterility Assurance Specialist
BH-316646
Posted: 23/10/2025
- Competitive rate
- Netherlands Provincie Zuid-Holland Leiden
- Contract
-
Life Sciences
Position: Sterility Assurance Specialist – Sterile GMP Manufacturing
A leading pharmaceutical development organization is seeking a Sterility Assurance Specialist to drive contamination control and sterility assurance across aseptic manufacturing operations. This role is instrumental in shaping a sterility-focused culture and ensuring compliance with GMP and regulatory standards, including Annex 1 (2022), FDA, EMA, and ISO classifications.
Key Responsibilities
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
A leading pharmaceutical development organization is seeking a Sterility Assurance Specialist to drive contamination control and sterility assurance across aseptic manufacturing operations. This role is instrumental in shaping a sterility-focused culture and ensuring compliance with GMP and regulatory standards, including Annex 1 (2022), FDA, EMA, and ISO classifications.
Key Responsibilities
- Foster a sterility-focused mindset across teams by implementing standards and controls that support regulatory compliance in facility, utility, equipment, and procedural design.
- Provide expert guidance on facility layout, cleanroom design, utilities, equipment selection, and process flows to minimize contamination risks.
- Oversee aseptic manufacturing of parenteral drug products, including lyophilized, solution, and suspension forms.
- Lead validation and qualification of critical systems and processes, including cleaning, sterilization, and utilities.
- Develop and sustain comprehensive contamination control strategies aligned with Annex 1 and industry best practices.
- Implement and maintain cleanroom classifications (ISO/FDA/EU) and enforce strict gowning and cleanroom behavior protocols.
- Optimize aseptic operations using barrier technologies (RABS, isolators) and ensure compliance across Grade A/B/C/D environments.
- Design and manage environmental monitoring programs (viable and non-viable), including setting alert/action levels and investigating excursions.
- Oversee sterilization systems (autoclaves, SIP, CIP) to ensure validated and effective operation.
- Plan and execute media fill simulations, including investigation and resolution of failures.
- Support container closure integrity testing (CCIT) and related sterility assurance activities.
- Participate in cleanroom qualification lifecycle stages (DQ/IQ/OQ/PQ) and review/approve validation protocols.
- Develop and deliver training programs on aseptic techniques, gowning, cleanroom behavior, and incident response.
- Maintain sterility assurance documentation including SOPs, protocols, validation reports, and investigation records.
- Lead risk assessments and troubleshooting during deviations, facility/process changes, and production ramp-up.
- Act as a subject matter expert during regulatory inspections, audits, and investigations related to sterility assurance.
- BSc/MSc in Microbiology, Pharmacy, or a related discipline.
- Extensive experience in sterility assurance within the pharmaceutical industry.
- Deep knowledge of GMP, contamination control, aseptic processing, validation, and regulatory guidelines.
- Strong technical expertise in cleanroom operations, sterilization technologies, and environmental monitoring.
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.