Validation Specialist

Are you experienced in validation of Finished Product processes within the pharmaceutical industry? Do you thrive collaborating in a dynamic environment and are committed to delivering stellar results?

If so, this is your moment. Join us in Device Manufacturing Development (DMD) Assembly & Packaging (A&P), a department where your impact matters. Seize the chance and apply today for a life-changing career.

The position

As Validation Specialist, your role involves close collaboration with manufacturing organizations in Novo Nordisk as well as a large portfolio of project teams in DMD. Your primary responsibility is to develop modern approaches to validation that ensures harmonization and simplification across A&P.

Your key tasks entail:

• Executing documentation and procedures to support standardization efforts
• Ensuring alignment of documents and templates with NN validation process, from Science- and Risk-based approach to validation, in line with the Fill & Finish Expansion (FFEx) Quality strategy
• Driving the implementation of documentation standards across various programs and projects
• Collaborating closely with internal FFEx program organization and specialists
• Communicating efficiently with stakeholders at all levels to ensure alignment and transparency

Qualifications

To be successful in this role, we believe you:

• Hold a minimum of a bachelor’s degree in a relevant field
• Possess hands-on experience in validation within the pharmaceutical or medical devices industry
• Demonstrate in-depth knowledge with regulatory requirements for validation, including drug, combination, and device products
• Showcase a keen understanding of validation processes and ensuring compliance with relevant internal and external regulatory standards
• Display proficiency in both spoken and written English

On a personal level, you possess exceptional communication skills, are adept at negotiation, and seamlessly connect with stakeholders. You excel in navigating diverse perspective and orchestrating decisions that align with the best interest of everyone involved, even in high-risk situations or when faced with differing opinions. You are not just a team player but also an inspiration, transforming challenging into opportunities for the team’s and business’ success.

About the department
You will join DMD and the A&P department, a key function supporting assembly and packaging of Novo Nordisk finished products, primarily pen injectors and tablets. We are bridging product development to production and driving development and standardization of new, smarter, and aligned processes.

Furthermore, we are responsible for establishing assembly and packaging capacity worldwide for new and marketed products in compliance with current regulatory requirements and in close interaction with the Novo Nordisk global production sites. We have an end-to-end presence from device development to production implementation and support to running production.

We are located in Hillerød and are a department that is growing rapidly, consisting of over 150 employees placed into different teams. At the office, we share an informal tone, great work morale and tall ambitions to be the best at what we do. Once you step into this role, you will join a diligent and highly competent team and be at the crossroad between Device and Delivery Solutions, Quality, and Production.
 

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 employees 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 Senior Manager, Hans Kristian Rømer Westh, at +45 30796795.

Deadline

2 May 2024.

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 to 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.