Novo Nordisk is expanding its manufacturing facilities in Kalundborg to support the portfolio within chronic diseases. We are hiring a TIMS (Test Information Management System) expert for this project – also called the M3 Project. The activities will take place at our Kalundborg site, which is Novo Nordisk's hub for API manufacturing.

Are you interested in being a part of a dynamic global company and working on an exciting new project for capacity expansion? This opportunity involves establishing new active pharmaceutical ingredients (API) manufacturing facilities that integrate new and automated technologies with strong expertise in biotech manufacturing.

Apply today and join us for a life-changing career!

The position
As TIMS expert you will be part of the overall project quality team setting the direction within quality for the new API production facilities. You will be the first line support to the local M3 TIMS users during testing (verification) activities.

Your main tasks will be:

• Participate in setting the direction on execution of validation testing activities in TIMS
• Administrate our local TIMS database (administer users and the set-up of the database)
• Perform classroom trainings for new M3 TIMS users
• Support set-up and roll out of new initiatives and systems related to TIMS
• Coordinate validation testing activities across the project

Furthermore, as TIMS Expert you will represent M3 in relation to corporate TIMS activities.

Qualifications
We are seeking candidates who fulfil the following prerequisites:

• You have a technical education e.g. Labtech, Bioanalytics, Production Technician or similar technical AP degree educations within IT solutions, pharmaceutical or engineering sciences
• Experience within GMP and pharmaceutical (API) manufacturing
• Proven experience working with IT solution supporting validation (preferably TIMS)
• Good understanding of project and validation activities within the pharmaceutical industry
• Strong communication skills with English proficiency (verbally and written).

As a person you have a high quality mindset and a structured approach. You can balance requirements against the progress of project activities You enjoy teamwork and are a strong motivator of others. You thrive in a multicultural environment that demands independence to make critical decisions, and you enjoy simplifying wherever simplicity can benefit reaching the goals faster.

About the department
We are a newly established department supporting the M3 project with specialist knowledge within GMP and validation throughout all project phases. We also support the entire area with training support during project phases and training development for the future operations.

We are currently approx. 20 employees and still growing. We have lots of fun at the same time as keeping up with the many questions from the M3 organisation around us.

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 Mie Boa Jacobsen, Senior Project Manager at phone +45 30 75 13 54.

Deadline
January 12th 2025

We care about your motivation, but 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 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.