Validation Lead - Expansion Projects

Category:

Project Management & Agile

Do you have expertise within aseptic production process? Are you an expert looking for a global position where you can drive Cleaning & sterilisation processes equipment design and validation standards globally? Are you ready to take on challenges and have fun at the same time?

If so, then you are the Cleaning & Sterilisation Process & Validation Engineer we are looking for. Apply now and join Novo Nordisk!

The Position

As Process & Validation Engineer within the CIP/SIP (Cleaning In Place & Sterilisation In Place) team, you will be a key player in defining the future global standard for equipment & processes for CIP/SIP and associated validation approach. You will work in collaboration with a wide network of stakeholders on a local and global level. This will include the CIPSIP Work Package Owner (WPO), Project Managers, Specialists, our Central Manufacturing Development Team, and local sites stakeholders.

Together with sites all around the world and suppliers of equipment and our engineering partners, you will develop and validation the best possible solutions.

While being stationed in Lyngby, you will travel to our global sites, including sites based in Denmark, France, US, Brazil, and China. 20% travel is expected for the position.

The main tasks will be to:
• Drive the development and validation for the CIPSIP equipment.
• Collaborate design development with suppliers going into oversight to ensure the solution is build according to the design.
• Be the key player during design qualifications, FAT - SAT - Qualification activities.
• Ensure the development of qualification approach that will enable a streamlined implementation of the standard solution.

Qualifications

To succeed in this role, you have:
• A bachelor’s or master’s degree in engineering/chemistry/biotechnology/pharmacy/natural sciences or similar. Cleaning & Sterilisation process experience is a bonus.
• Hands-on experience with project, qualification and validation activities
• At least 3 years of project execution or validation experience within Aseptic process, pharma, or similar areas.
• Experience in GMP in the pharmaceutical, biotechnology or similar industry.
• Excellent stakeholder management skills and experience working cross-functionally with various cultures, job functions, and experience levels.

As a person, you are focused on quality, as well as deliverables and have the drive to create new solutions. Your forward-thinking and visionary outlook allow you to anticipate future trends and promote process optimization and digitalization alongside your colleagues.

With your global citizen mentality, you are a collaborator at heart and work seamlessly with your colleagues to deliver exceptional outcomes that meet and exceed expectations, requiring excellent communication skills to build trusted relationships cross functionally and globally.

For this position, you are required to be fluent in spoken and written English. As you will be working globally with the Danish sites, US, Brazil, France and China, language skills within these areas would be advantageous.

About the Department

Technology Standards is a department in the newly created area of Fill & Finish Expansions. Fill & Finish Expansions is anchored in Product Supply, which globally accounts for +19,000 of Novo Nordisk’s +50,000 employees. The responsibility of Fill & Finish Expansions is to plan and execute the establishment of new aseptic filling capacity across the global manufacturing network. Including BioTech and Rare Diseases (BRD) and Injectable Finished Products (IFP) for new filling platforms while ensuring harmonisation and global standards. Across the different roles there is a distinct global aspect as the end goal is a global standard and best practice, and working with multiple sites, cultures and traditions will be a key element.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.

Contact

If you want to learn more about the position, Senior Manager Formulation and W&S Bo Hove Vanting Andersen on +45 30790408 or Senior Project Manager Jia Gu on +45 30754040.

Deadline

Apply before April, 19 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 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.