Validation Specialist for Medical Device Development

Do you want to make a difference in lives of our patients, and are you eager to set direction for our equipment and test method validation in device and primary packag-ing testing and verification? Are you extremely well versed in design verification and compliance and eager to im-prove the processes to increase our efficiency and ensure an adequate compliance lev-el? Then you may be our new Device Verification Specialist.

The position
The role as Validation Specialist is a versatile role working with multiple stakeholders from line management, QA, and process experts, test- and validation engineers as well as commercial device manufacturing. You will be setting direction and making strategic decisions for our Science and Risk Based Validation approach on medical de-vice and delivery solution development testing, and as well as participating in relevant internal SRV process groups and process manager groups in DDS. 

You will be responsible for interpreting requirements along with our QA colleagues, and ensuring our processes and quality systems are compliant with the relevant re-quirements, as well as continuously simplifying and optimising these processes to en-sure robust and scalable test methods from development to our finished goods pro-duction. Driving and participating in deviations or A3 problem solving is a key activity in the role. 

Finally the job also entails training, guiding and supporting colleagues in close collab-oration with our other specialists within verification, dosing and equipment, to ensure support to the device and delivery solution development projects with high quality and timely test equipment and test methods.

Qualifications 
You hold a degree in for example engineering or natural science or alternatively you have a relevant background from the medical device industry working with medical device regulations and compliance. A minimum of 8 years of experience within qualifi-cation equipment and process validation is required.

Knowledge of SRV is considered a minimum, and significant experience in optimising working processes is needed for succeeding in this job.

As a person you are structured, natural collaborator, and a solid communicator with a strong drive for simplifying our approach to qualification and validation processes and an ability to cut through complexity within the compliance framework. You are a team player who can support and empower your colleagues through capability building and are keen on supporting the leadership team in setting direction within Science and Risk Based Validation.

About the department 
Devices & Delivery Solutions (DDS) has a long and outstanding track-record of devel-oping the best, most innovative, and widely used injection devices in the world. In the development of medical devices, we ensure that user insights and innovation go hand in hand with a strong quality mindset.

Testing & Verification plays an important role in the medical device and primary pack-aging development process, as we deliver specialised exploratory testing and design verifications. It is our responsibility to specify, develop, purchase, and validate new test equipment to support and conduct verification testing of medical devices and de-livery solutions.

If you join our department, you will get 60 passionate colleagues with different back-grounds, including laboratory technicians, engineers, and other specialists. 

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For em-ployees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact
For further information, please contact Manage Filippo Cavalca +45 3448 2240 or Di-rector Maria Forman on +45 3075 1763.

Deadline  
4 May 2025

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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.