Are you driven to use your knowledge and experience to help others succeed? Are you ready for a work life where focus is on quality and delivery of life-saving medicines to our patients within intralogistics at our global future Fill & Finish sites?

If you have experience in validating production equipment in a GMP environment and are eager to work on dynamic, global projects, we’d love to hear from you! Join us, and let’s shape the future together!

End of 2024, Novo Nordisk acquired the manufacturing site Catalent Anagni S.r.l. with the ambition to expand our capacity to meet the needs of millions of patients. You will be part of a global team that will develop the pharma facilities of the future and work with advanced technology to rethink our fill & finish facilities.

The position

Novo Nordisk is investing massively in new production facilities around the globe. With this expansion we will contribute with the important role of producing future products - and you will get an opportunity to be a part of it.

As our Validation Specialist, you will be at the forefront of driving global validation efforts for our key improvement and innovation projects for new and existing production facilities. The validation activities will be focused on equipment, packaging, assembly, intralogistics and warehousing.

Your main responsibilities will include to:

• Establish validation documentation aligned with global requirements for new solutions, while overseeing testing and qualification at initial installations
• Plan and execute validation activities/risk assessments in accordance with regulatory requirements
• Collaborate with engineering and operations teams to perform validation testing, analyze results, and address any non-conformities or discrepancies
• Ensure compliance with safety, quality, and environmental standards, while also participating in continuous improvement processes across Novo Nordisk
• Review design and documentation from suppliers

All of this will be done in collaboration with project managers, manufacturing teams, and specialists.

Your role will be instrumental in ensuring successful project outcomes, from concept to implementation, in close collaboration with cross-functional teams and global manufacturing sites. You will take ownership of validating new solutions, establishing key documentation, and overseeing testing processes to ensure our production systems continue to meet high standards of quality and efficiency

Qualifications

To succeed int this role, you have:

• Knowledge of Validation (VPL, DER, DQ, IOP/Q, Risk assessment) and general Quality Management Systems.
• An academic degree in engineering/life sciences or a related field
• Several years of experience as a Validation Specialist/Engineer
• Experience within GMP regulated environment will be extremely beneficial
• A good understanding of science and technical aspects of manufacturing processes
• Proficiency in English communication

On a personal level, you are an experienced professional who is open-minded and thrives on seeking opportunities through collaboration. As you will be working closely with external partners, your ability to build strong, productive relationships is key. Excellent communication and interpersonal skills will be essential for navigating these partnerships and ensuring smooth collaboration. These qualities will be critical to your success as you help drive innovation and excellence across our global projects.

About the department

Fill & Finish Expansions belongs in the newly established Fill & Finish area. The new area is working to increase the fill & finish production capacity across the Novo Nordisk network to ensure we continue to deliver high quality products for our patients, also in the future.

You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success.

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.

Deadline

27 March 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.