Sterility Assurance Specialist

At the end of 2024, Novo Nordisk acquired the Catalent Anagni S.r.l. manufacturing site with the ambition of expanding our capacity to meet the needs of millions of patients. You will be joining a global team working on pharmaceutical plants that utilize advanced technologies within the site's fill & finish facilities.

Are you an expert in sterile production techniques? Do you have a passion for ensuring the highest quality standards in pharmaceutical manufacturing? We are seeking a Sterility Assurance Specialist to join our fantastic team!

If you have the skills and experience to make a difference, read on and apply today for a life-changing career in our Anagni Site!

The Position

In this role you will ensure the quality and safety of our sterile products. This is an exciting opportunity to contribute to cutting-edge technologies and work alongside a dynamic, multidisciplinary team.

As a Sterility Assurance Specialist, you will:

1. Provide expertise in sterile production, including aseptic techniques, RABS, and isolators.
2. Design and implement aseptic process simulations for line start-ups and routine planning.
3. Develop and manage contamination control strategies, incorporating environmental sampling and personnel qualification, sanitization program, environmental data analysis, risk assessment approach, continuous improvement in aseptic technique application, by thinking with open mind and applying innovative solutions while ensuring adherence to standards.
4. Collaborate with multifunctional teams both on the start-up of aseptic filling lines and in routine planning.
5. Conduct risk assessments and manage investigations and deviations related to sterile products, ensuring continuous compliance.

This is a hybrid position, requiring at least 3 days per week on-site in Anagni.

Qualifications

To be successful in this role, we imagine that you have:

1. A specialist bachelor's degree and experience in quality operations or production.
2. Not less than 3 years of experience in Sterility Assurance in pharmaceutical, biotechnology industry.
3. Experience in microbiology or a scientific degree.
4. Proficiency in English, particularly in written communication is a must.
5. Robust knowledge of manufacturing processes, products, documentation, and procedures.
6. Knowledge of Regulations related to Aseptic Production (with focus on Annex 1).
7. Solid expertise in aseptic techniques and processes.
8. Knowledge of commonly used software and hardware tools.

About the Department

You'll join a dynamic and strong team of 10 talented professionals with diverse seniorities and expertise reporting directly to the Sterility Assurance Manager. This role offers the opportunity to collaborate not only within your team but also cross-functionally with all site departments in a rapidly growing site and with all sites of Novo Nordisk network. The team had the opportunity to take part to all processes of continuous improvements of existing processes and of new lines under implementation on the site.

Working at Novo Nordisk

At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales - we're all working to move the needle on patient care.

Contact

We can't accept directly sent CVs, please submit your application via the 'Apply' Button.

Deadline

Apply before April, 8th 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.