Validation Project Specialist

Are you driven by creating governance structures that ensure global solution generation and adherence to the execution standard? Would you like to be part of developing and setting direction within Validation, Qualification, and Verification at our future Fill Finish sites at Novo Nordisk? If yes, then you might be the Validation Project Specialist that we are looking for. Apply for this exciting job opportunity at Novo Nordisk!

The Position
As our Validation Project Specialist, you will drive the development of Validation Standards department and support for Fill Finish Expansion (FFEx) sites. That includes scientific support on validation setting direction for FFEx on Validation standardization and supporting roll out, improvement and continuous alignment with stakeholders. You will proactively plan future standardization solutions and initiate work structures to support development, alignment and timely deliverable.

Your activities will include:
•    Driving solution development for SRV interpretation and assuring global alignment through cooperation, global work structures and taking needed decisions to ensure progress.
•    Improving standards and execution setup through feedback and adapting our strategies.
•    Leading global SRV groups and aligning strategies across FP/AP (with focus on stakeholder management, roles and responsibility definition, tools and governance and taking initiative when change is needed).
•    Together with QA develop audit strategy that supports concurrent SRV/GMP alignment with NN stakeholders (Internal audit).
•    Establishing protocol generation setup for FFEx.

Your workplace will be based in Lyngby, but as there is collaboration required on a global scale, some travel might be required. It is estimated this will be 3-4 times per year.

Qualifications
As the ideal candidate, you have the following skills and qualifications:
•    A Master’s degree in Natural Science or similar area.
•    10+ years of experience working within QA, GCM, QC, manufacturing process, products and projects.
•    Strong understanding within compliance, QMS, GMP requirements and pharmaceutical industry practices, key processes and support functions.
•    Hands-on operational experience within Validation and Qualification for greenfield projects and product development/technical transfer projects.
•    Strong project management skills with experience executing complex projects on a global scale. 
•    Great stakeholder management skills and building relations in a global context.
•    Fluency in written and spoken English.

About the Department
You will be joining Fill & Finish Expansions, a newly established and growing area within Novo Nordisk. Our team is responsible for designing, planning, and building major Fill & Finish Expansion projects across Novo Nordisk. We are dedicated to serving the needs of millions of patients by rethinking our Fill & Finish facilities with the use of modern technology. With a global approach, you will have the opportunity to work with multiple sites and cultures across the world.

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 
For further information, please contact hiring Manager Kenneth Petersen (Director Validation Standards) at KP@novonordisk.com or Kenneth Olsen (VP, FFEx Validation) at hkol@novonordisk.com. 

Deadline
1 July 2025. 

You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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.