Local Senior Validation Specialist - Pilot Plant, Mørdrup

Do you want to play a key role in defining and driving robust, compliant, and efficient validation practices across both production and innovation?

At Coloplast, we are looking for an experienced and proactive Local Senior Validation Specialist to strengthen our validation capabilities in the Pilot Plant in Mørdrup. You will take ownership of the local validation strategy, act as subject matter expert, and lead cross-functional validation initiatives that bridge development and manufacturing while ensuring compliance and efficiency.

Welcome to the Pilot Plant – bridging innovation and production

You will be part of Mature Manufacturing, reporting directly to Head of Mature Manufacturing, Anders Virring. The Pilot Plant plays a unique role in Coloplast, connecting product development and full-scale manufacturing. You will collaborate closely with Product Support, QA, Engineering, and R&D, ensuring that validation activities meet regulatory and quality requirements while enabling innovation and smooth operations.

Get a flexible and dynamic workday

In this senior role, you will act as the local validation lead in Mørdrup and be responsible for defining, planning, and executing the validation activities. You will represent validation in local forums, provide expert guidance to cross-functional teams, and maintain close alignment with the Global Validation team in Humlebæk. Your focus will be on ensuring robust validation of cleanrooms, production equipment, and manufacturing processes while verifying good quality products as an outcome of the processes.

Specific tasks further include:

• Define and drive the local validation strategy in alignment with global standards

• Take the lead on validation projects across Pilot Plant – ensuring lean and compliant processes

• Perform and oversee (re)validation of cleanrooms, production equipment, and manufacturing processes, including creating IQ, OQ and PQ protocols and reports.

• Act as subject matter expert and advisor for validation methodology, risk assessment and documentation practices

• Facilitate and document process risk assessments (FTA) and define risk control strategies for validated processes

• Coach and support engineers and specialists to strengthen validation competencies locally

• Collaborate with Product Support, QA, R&D, and Production to ensure aligned validation practices

• Maintain and improve local validation instructions, templates, and tools

• Contribute to the continuous development of validation principles in collaboration with Global Validation

Solid validation experience and strong collaboration skills

You have a relevant education within engineering, pharmacy, chemistry, or natural sciences, combined with at least 5 years of experience within validation of production processes and/or equipment in a regulated environment (medical device, pharma, or biotech).

You thrive in a hands-on validation execution yet strategic role where you collaborate across functions, , and translate complex requirements into clear, practical solutions.You are confident in leading validation decisions and challenging existing practices to drive improvement and compliance.

On a personal level you have:

- Good English skills, fluent verbally and in writing

- Strong documentation skills

- Data analysis skills including statistical understanding (when analyzing validation Ppk results)

What we offer

You will join a highly skilled and collaborative environment where knowledge sharing, compliance, and innovation go hand in hand. The Pilot Plant combines the agility of local production with the innovative spirit of R&D – giving you the opportunity to shape how validation is performed locally while being part of a strong global validation community.

As a senior specialist, you will have a unique opportunity to influence both methods and mindset around validation, ensuring a strong foundation for future growth and product robustness.'

Interested:

If you would like to know more about the position, please contact Anders Virring, Head of Mature Manufacturing, at +45 4911 2894.

We will review applications on an ongoing basis, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

60125
#LI-CO