Are you experienced in Sterility Assurance and looking for an opportunity to make a difference in people’s lives? Do you have a deep understanding of Sterility Assurance strategies and methodologies, and the ability to lead complex projects in a dynamic environment? Then you might be the Sterility Assurance Senior Expert we are looking for! Keep reading to know more

The role 

The Sterility Assurance Expert ensures that aseptic manufacturing processes consistently meet sterility and compliance standards. This role focuses on maintaining a contamination-free environment and implementing best practices to safeguard product quality. It plays a key part in upholding regulatory requirements and driving continuous improvements in sterility assurance. The incumbent will: 

• Implement and Maintain Sterility Assurance Practices – Oversee aseptic processes, microbial control, smoke testing, and sterility assurance systems to ensure compliance. 

• Evaluate Environmental Monitoring & Contamination Control – Manage viable/non-viable monitoring, bioburden containment, facility cleaning/disinfection, and HEPA filter certification. 

• Support Media Fill Testing & Smoke Testing – Ensure proper execution and validation of these critical sterility assurance tests to confirm aseptic process integrity. 

• Manage Deviation Investigations & CAPA Execution – Perform impact assessments, root cause analyses, and implement corrective/preventive actions for sterility-related issues. 

• Support Audits, Regulatory Compliance & Continuous Improvement – Ensure adherence to GMP guidelines, prepare sterility assurance documentation, and drive process innovations. 

  

Qualifications 

• Education & Experience – Bachelor’s or Master’s degree in Life Sciences (Microbiology, Biotechnology, Pharmacy, etc.) with at least 7 years of experience in Quality Assurance and Sterile Manufacturing. 

• Sterility Assurance Expertise – Strong knowledge of aseptic processing, microbiology, contamination control, media fill testing, smoke testing, and environmental monitoring. 

• Regulatory & Quality Compliance – Familiarity with GMP regulations, sterility assurance guidelines, and Quality Management Systems (QMS), including deviations, CAPAs, and change controls. 

• Communication & Language Skills – Fluent English is mandatory, with French as a strong advantage for effective collaboration and training. 

• Problem-Solving & Leadership – Ability to perform root cause analysis, impact assessments, data interpretation, and effectively train, influence, and collaborate with cross-functional teams. 

  

About the site 

End of 2024, Novo Nordisk acquired the manufacturing site Catalent Belgium SA. The site is now part of Novo Nordisk and has begun the transition to become a fully integrated Novo Nordisk manufacturing site. To advance the integration, the Brownfield Site Integration team for Brussels (BSI Brussels) has been established with the responsibility for local integration and capacity maximization in collaboration with the local team.  

About Novo Nordisk  

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 63,400 employees. Together, we go further. Together, we’re life changing.  

  

Contact  

If you believe you are qualified, and are willing to take the challenge, please send your CV directly via our online application tool.  

  

Application deadline  

Please apply before  21/02/2025  

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.