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Process Engineer, Pilot Plant


Espergærde, DK

Job Family:  Research & Development
Country/Region:  Denmark
Process Engineer, Pilot Plant 

Pilot Test Method & Validation Specialist

Looking for a chance to work in an innovative R&D Pilot Plant and become the one point of contact for new test methods and validation?

Help us develop brand new medical devices and become part of the development process – from initial design to final production – where you will play a crucial role in taking our test methods to the next level with a focus on simplicity and transparency in our ways of working.

“Essentially, your work will ensure that our customers can put their trust in our products. In that way, you’ll make a true difference to people with intimate health care needs,” says Pernille Guldager, Director of Pilot Plant, Material Processing.


Join our R&D Pilot Plant
At our Pilot Plant in Espergærde, you will become part of an innovative and data-driven R&D set-up where you will join our Material Processing department. Here, you will get 38 colleagues responsible for the production of medical devices within our Wound Care and Chronic Care business areas. 

We also develop, mature and validate production processes to enable new innovative products and ensure the quality of our products is as high as possible. And this is where you enter the picture.

“We’re a quite diverse team with an international vibe. Working in an innovative and fuzzy environment in development projects is something we love, and we enjoy the  open and collaborative atmosphere,” Pernille continues.


Ensure high quality of our test methods
With validation responsibility and as our local superuser for our new test methods, you will get a very important role. You will collaborate closely with another test method specialist covering the Supply value stream at Pilot Plant and be the first point of contact for our process engineers and technicians and project managers in Pilot Plant. Further, you work cross-functionally within R&D, with our Quality Lab and the Global Test Method and Validation teams.


Ensuring the right level concerning the design, development and validation of test methods, qualification of test equipment and validation of processes, you will:

•    Share knowledge about test methods and test principles through close collaboration with process specialists and test method specialist in R&D and Global Quality, providing input to development of new test methods
•    Increase the level of test method understanding at our Pilot Plant through training of specialists, technicians, operators and others in test methods and use of test equipment  
•    Participate in IVS (Innovation Value Stream) projects, support Pilot Plant specialists and also drive the development of own test methods for i.e. for process validation 
•    Create validation documentation for production-related test methods 
•    Maintain the local overview of manufacturing process validation activities at our Pilot Plant and coordinate with the Global Quality Validation team
•    Create and approve validation documentation for manufacturing processes at Pilot Plant and supervise consultants

Technical background – with skills for test methods
As you will be working hands-on with the test method development as well as supervising process specialists, you need to be able to work well with colleagues and have excellent communication skills to ensure we create just the right test methods. 

You also like working in an innovative environment where agendas can change – and where you need to think out of the box.


Moreover, we imagine that you:
•    Have solid experience with design control, validation and test method development from a regulated industry – preferably within the medical device industry
•    Take an analytical approach to your work and have knowledge of statistics and statistical software (e.g. SAS JMP or Six Sigma) 
•    Have knowledge of ISO 9001 and, preferably, also ISO 13485 and GMP
•    Speak and write English effortlessly


If you would like to know more about the position, please call Director of Pilot Plant, Material Processing, Pernille Guldager on +45 49 11 22 56. We will take candidates into the recruitment process continuously, 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 12.000 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.


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