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Senior Test Method Validation Scientist


Humlebæk, DK

Job Family:  Research & Development
Country/Region:  Denmark
Senior Test Method Validation Scientist 

Senior test method validation scientist for Research and Development (R&D) – Chronic Care and Wound Care
Would you like to provide documentation to help one of the best-performing medical device companies in the world ensure product safety for chronic care and wound care globally?
 Pursue a career within one of the best-performing medical device companies in the world and be part of the entire development process – from initial concept tests to final product. Feel the pride and see your efforts help make a difference to people with intimate health care needs.
Join our Release & Actives department in Material Technology
Joining our Release & Actives department, you will work alongside 20 skilled colleagues. Here, we ensure proper design and documentation of our new products within the chronic care and wound care business areas. Thus, you will collaborate closely with other parts of R&D and production QA in the documentation process of test methods but also with our 3 other test method validation scientists, who are based in Humlebæk, Denmark. 
“Before new or existing products are brought to the market, we ensure the right documentation for our design verification and production test methods. This is crucial for us to make sure our customers can put their trust in our products,” explains Head of Chemical Analysis & Test Method Validation Kirsten Stuckert. 


As a test method validation scientist, you are responsible for ensuring documentation at the right level concerning the design and validation of test methods used for design verification and test methods used in our productions. This means that you participate in creating documentation for test methods and related procedures and instructions.
Participating in the constant development of test method principles and structures in R&D, you will:
•    Be responsible for creating and approving validation documentation for design verification and production-related test methods and equipment for medical devices.
•    Be responsible for transfer of developed test methods and related test equipment to our pilot plant in Denmark or our international manufacturing sites.
•    Be responsible for keeping track of needed test methods and the needed documentation in selected project and ensuring deadlines are kept.
•    Assist in projects and the ongoing maintenance of test methods implemented in our production.
•    Assist in troubleshooting of laboratory equipment as well as in the design of new test equipment/test methods.
•    Aid in the training of colleagues in test methods and procedures as well as in the design of new test methods.
•    Assist in ongoing update of procedures and instruction to ensure we are in compliance with current legislation.
Scientific background and a flair for test methods
We imagine that you:
•    Hold a master’s degree within science (e.g. mechanics/physical, chemistry, pharmacy or similar).
•    Like to perform documentation work for example: Documentation work related to test method validation or equipment qualification related to medical devices or drugs.
•    5-10 years’ experience from industry with a proven track record, concerning validation documentation or related quality documentation. 
•    Have knowledge of statistics and statistical software related to test method validation (e.g. SAS.jmp).
•    Probably have knowledge of polymers and mechanical testing – but we would also like to hear from you if you have knowledge of chemical testing and Six Sigma.
•    Take an analytical approach to the assessment of corrective and preventive actions and have an advanced level of problem-soling skills.
•    Have knowledge of ISO 9001 and, preferably, also ISO 13485 and GMP.
•    Have good English reading, written and spoken skills.


Personal qualifications
As you will not carry out the test method design part yourself, you must be able to work well with colleagues, give your feedback to ensure we create just the right test methods – and meet deadlines. As a person you are dedicated, open-minded and curious and a person who likes to work in teams. You are structured and proactive, so you deliver and drive your documentation tasks as agreed and able to keep structure on several projects at the same time. You thrive in interdisciplinary settings and can manage and communicate with both internal and external stakeholders with different backgrounds. We have an informal approach in the team, a positive mindset and a sense of humour is appreciated.
Interested in this position as senior test method validation scientist?
At Coloplast, we make sure that you can be you. That is why we encourage applications from suitably qualified and eligible candidates regardless of sex, race, ethnicity, disability, age, sexual orientation, gender reassignment, religion or belief or marital status.
If you would like to know more about the position, please call Head of Chemical Analysis & Test Method Validation, Kirsten Stuckert, at +45 4911 1331 or R&D Principal Scientist Karina Dixen +45 4911 2329. 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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