GMP Qualification Specialist

Are you driven by operational excellence and a strong interest in GMP equipment qualification and validation in a high-impact life science setting? Do you excel at generating and reviewing qualification documents to a high standard, ensuring compliance and facility inspection readiness at all times? If so, you could be the GMP Qualification Specialist we’re looking for.

Novo Nordisk Foundation Cellerator is leading the transformation of the cell therapy landscape by developing and operating a state-of-the-art process development and GMP manufacturing facility at the Technical University of Denmark (DTU) in Lyngby. Our advanced ATMP facility, currently under greenfield construction, is scheduled to commence operations in Q3 2027 and will be ready for regulatory inspections by Q3 2028. As a philanthropic entity, Cellerator is dedicated to accelerating the progress of cell-based therapies, serving both academic institutions and industry partners. Our mission is to foster significant growth in regenerative medicine for the benefit of patients and society.

The job

As our GMP Qualification Specialist at Cellerator, you will take a key role in the commissioning and qualification of facility utilities and equipment and the preparation for operational readiness. This is a unique opportunity to be part of a team, planning and implementing a new dedicated cell therapy manufacturing facility, which will provide much needed ATMP infrastructure in Denmark.

In addition, you will have the opportunity to go beyond the facility and equipment qualification and be part of the GMP manufacturing team, establishing new manufacturing processes and procedures, and to generate cell therapy production batches to GMP for early phase clinical trials.

You’ll work closely with other functional teams such as QA and QC, as well as process development, ensuring facility and equipment readiness for manufacture, solving tech transfer challenges and ensuring product quality and safety to the highest standard.

Your key tasks will include: 

Equipment Qualification: Generate and review equipment IQ/OQ and PQ protocols and reports. Oversee calibration, service and maintenance schedules as part of the equipment lifecycle management.

Compliance & Quality: Ensure the GMP equipment meets all regulatory requirements (EMA, FDA, GMP, EHS) and is inspection-ready at all times. Generate and review non-conformances, deviations, CAPAs and change controls within the Quality Management System.

GMP Manufacturing: Support manufacturing readiness and execute GMP batch manufactures according to approved SOPs and Batch Manufacturing Records. Perform batch reviews to ensure GMP compliance at all times. Participate in deviation investigations and CAPA implementation.   

About you

• Professional, quality-conscious, solution and impact-oriented with a strong customer focus
• Attentive to details and on delivering results of high quality
• Strong organizational skills with the ability to work independently as well as within a team
• Excellent team player, who enjoys frequent interactions between internal and external contacts
• Ability to work to deadlines and priorities workload accordingly
• Strong interpersonal skills and ability to build good working relations
• Excellent verbal and written communication skills (English)

You should have:

• Bachelor’s or Master’s degree in engineering, life sciences or related field or equivalent experience
• 2-5 years of experience in a GMP manufacturing environment (biologics, ideally ATMP)
• Equipment qualification and validation experience
• Experience in compliant operation of class B, C and D clean rooms

You thrive in a changing and dynamic work environment, and in a job that requires you to take initiatives and think out of the box when challenges occur. You have strong collaborative skills and the ability to build good relationships with the people around you.

What we offer

At Cellerator, we offer more than just a job— we offer the opportunity to be part of something bigger. When you join our team, you’ll become part of a dynamic and purpose-driven environment focused on accelerating life science innovation in Denmark and beyond. 

Here’s what you can expect:

• A High-Impact Role: Join a fast-paced, mission-focused team working at the intersection of science, business, and innovation. You’ll collaborate with leading figures from the Danish life science ecosystem as well as influential European and global partners.
• A Values-Driven Culture: Be part of an organisation rooted in the Novo Nordisk Foundation’s strong values. We are deeply committed to fostering a diverse, equitable, and inclusive workplace where all employees feel supported, respected, and empowered to thrive.
• Flexibility and Growth: We offer a flexible working environment that supports your personal and professional development. From individual learning opportunities to team-based innovation challenges, your growth is our priority.
• Attractive Compensation & Benefits: Enjoy a comprehensive benefits package designed to support your well-being — including competitive salary, pension, vacation, health offerings, and more.
• A Great Place to Work: Our modern office is designed to foster collaboration and creativity. We provide healthy lunches, snacks, and great coffee to keep you fuelled throughout the day.

Next step  
If you have any questions regarding the position, please contact Novo Nordisk Foundation Cellerator Heike Lentfer, +45 20 91 37 99

To apply, please send your CV and a short cover letter. We review applications continuously, so we encourage you to apply as soon as you can.

About Novo Nordisk Foundation Cellerator

Cellerator is a pioneering initiative dedicated to accelerating the development and manufacturing of cell-based therapies. Located in Lyngby, Denmark, our state-of-the-art facility is designed to bridge the gap between laboratory breakthroughs and clinical application, enabling transformative treatments for chronic and life-threatening diseases.

Our mission is to empower researchers and innovators by providing GMP-compliant manufacturing, process development, and regulatory support for a wide range of cell therapy types—including those derived from pluripotent and adult stem cells. We serve both academic institutions and industry partners, fostering collaboration across sectors to advance regenerative medicine.

As part of the Novo Nordisk Foundation’s strategic commitment to health and sustainability, Cellerator operates as a philanthropic entity with a strong focus on impact and excellence. We are building a dynamic, inclusive, and purpose-driven workplace where curiosity, collaboration, and scientific rigor thrive.

In the coming years, Cellerator will expand its capabilities and team, offering exciting opportunities to be part of a growing organization at the forefront of cell therapy innovation. Join us in shaping the future of medicine—where your work contributes directly to improving lives and advancing science.