Sterilisation Specialist

Would you like to provide invaluable insight on product sterilisation validation to help one of the best-performing medical device companies in the world to ensure product quality globally?

If so, join a highly engaged team operating in a dynamic and professionally challenging working environment, where you will have the opportunity to grow and expand these skills even further collaborating with a large network of stakeholders and ensuring that our QA deliveries meets applicable requirements.

Join an international team
As part of the Sterilisation & Microbiology team, you will be working alongside 3 Sterilisation Specialists in Humlebæk as well as with the team’s 3 Sterilisation Engineers/Specialist working in Hungary. You will also experience a close work relation with the team manager for our microbiology laboratory including the 2 Laboratory Technicians and 1 Student Assistant working across the team. Together, we deliver solutions within sterilisation, mainly radiation and ethylene oxide and related to microbiological quality of Coloplast products in the areas of Chronic Care, Wound Care and Consumer Care.

 “Joining a team of highly experienced colleagues with degrees in science, pharma and engineering, you will receive thorough training and have a dedicated mentor to welcome you on board,” says Head of Sterilisation Rikke Christensen.

Participate in projects across product development and supply value stream
Dividing your time between daily operations and projects, you will participate in the development of new products and maintenance of the existing portfolio in collaboration with colleagues across Coloplast.

Identifying appropriate procedures and coordination with suppliers around the world, you ensure that the sterilisation process runs smoothly within the agreed time and at the required quality. In connection with this, you will have up to 20 days of international travel per year.

Specifically, you:

• Co-ordinate validation/re-validation of sterilisation processes for new and existing products and approve documentation
• Support developmental projects as a sterilisation resource
• Ensure documentation of validity of sterilisation after transfers and material/design changes
• Support our production sites in Denmark, Hungary, China and Costa Rica with sterilisation competencies

 “At Coloplast, you go to work knowing that you are helping create products that improve the daily lives of people around the world. That’s something that matters greatly to all of us here,” says Head of Sterilization Rikke Christensen.

Scientific background and an interest in sterilisation

• You hold an MSc in e.g. pharmacy, microbiology or engineering and have experience with or an interest in sterilisation by radiation and ethylene oxide
• Ideally, you have experience in a related field e.g. microbiology or polymer science
• You have knowledge of relevant standards ISO9001/ISO13485 and ideally experience from the medical device industry within quality, design control, change control, audits or similar
• Preferably, you have knowledge of clean room production
• You speak and write English fluently

To succeed in this role, it is essential that you appreciate the importance of setting guidelines and procedures and enjoy taking a highly systematic and detail-oriented approach to your work. On a personal level, you are highly driven and know how to take ownership of your tasks and push an idea through. You enjoy working in a dynamic and changing environment. Being both patient and steadfast by nature, you can push for results and confidently accept or reject solutions when you deem it necessary. Finally, your co-ordination skills enable you to collaborate with colleagues across levels and functions as well as with suppliers all over the world.

Interested? 
If you would like to know more about the position, please write to Head of Sterilisation, Rikke Christensen by mail: dkrla@coloplast.com. 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 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.

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