Hillerød, Capital Region of Denmark, DK
9 days ago
Validation Lead for Global Contract Manufacturing Devices

   

Are you a detail-oriented professional with expertise in medical device validation? Are you able to navigate critical validation processes on new production lines, and lead validation strategy? If so, we want to hear from you!

 

Join us at Hillerød as our next Validation Lead at Global Contract Manufacturing Devices (GCMD) – apply now!

 

The position
As a Validation Lead, you will be the validation expert for the team, responsible for leading the alignment and implementation of Validation Strategies within the department. In this role, you will be responsible for planning, executing, and reporting on validation activities for medical devices. Your role will involve direct engagement with Contract Manufacturing Organizations (CMOs) to effectively translate validation needs into actionable plans and protocols, ensuring compliance with ISO standards and medical device directives.

 

Your primary tasks will include:

Leading the alignment and implementation of Validation Strategies across the department, while maintaining associated documentations Acting as the validation responsible for the team, providing expert guidance on validation processes and ensuring compliance of documentation for GCMD, Assembly, and Pack (e.g., pFMECA, pFMEA, DER/DQ, CIL, URS, CR) Serving as the validation expert and the primary contact for CMs, assisting with validation when adding new equipment, implementing changes to critical processes, and collaboratively conducting validation activities Training and supporting colleagues and CMs in validation concepts and strategies while facilitating clear communication Proactively solving obstacles related to validation processes and ensuring that critical aspects are understood and addressed on new production lines Participating in the Corporate Process Group: Validation, including monitoring compliance signals and tasks initiated by the process group Ensuring audit readiness for validation-related documentation and supporting the team during audits

 

Qualifications
Your experiences include:

Degree in a relevant field +8 years of experience in validation of production equipment within the medical industry, with proven experience in developing validation strategies and protocols Experience with validation of highly automated equipment for high volume production – preferably within assembly and packaging environment Familiarity with GMP, ISO standards, and medical device directives (e.g. ISO 13485 and 21 CFR Part 820 regulations) Fluent English (both spoken and written); proficiency in Danish is a plus

 

On a personal level you are a proactive and highly organized professional ready to take on new challenges. Your strong communication and interpersonal skills will enable you to foster collaboration and effectively address validation needs across the team and with CMs.

 

About the department
You will join Technical Operations, Assembly and Pack in Global Contract Manufacturing Devices (GCMD), located in 24A at site Hillerød, Denmark. Technical Operations is a senior director area where approximately 70 colleagues work across six teams. Together, we assemble the mechanical Motor Modules for FlexTouch® (sub-assembly) and prepare for the technical support of new and existing devices. We deliver large quantities to our sister factories, which handle final assembly and packing. Our team is dedicated to delivering strong results that contribute to the success of Novo Nordisk by ensuring high-quality components at a competitive cost for our customers within prefilled devices.

 

We share a relaxed tone and high ambitions, and we pride ourselves on never compromising on quality or safety. Over the last five years, our FlexTouch network has consistently delivered according to plan, and often beyond – it is our ambition to continue with this trend and build team that will enable that.

 

Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the most valuable companies in the world. Our success relies on the joint potential and collaboration of our more than 70,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.

 

 

Contact
For further information, please contact Manager, Peter Specht Kristiansen, at pkii@novonordisk.com

 

Deadline

20 July 2025


You do not need to attach a cover letter, but please include a brief statement about your motivation for applying in your resume or CV. Kindly upload your CV in English and ensure that it does not include a photo to facilitate an efficient and fair recruitment process.

 

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.

 

 

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