Sterilisation Engineer

About the department:

The position is placed in our Sterilisation Team in Hungary, but with direct reporting to Head of Sterilisation, in Global Quality, Regulatory Affairs and Sustainability in Denmark. Therefore, you will work closely with the Sterilisation & Microbiology Team consisting of 4 skilled colleagues in DK and 2 skilled colleagues in Hungary. We are the department globally responsible for sterilization and microbiology. Together, we deliver solutions within sterilization, mainly radiation and ethylene oxide and related to microbiological quality of Coloplast products in the areas of Chronic Care, Wound Care and Consumer Care.

It is 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 by collaborating with a large network of stakeholders and ensuring that our QA deliveries meets applicable requirements. There is an expectation for this position to have up to 20 days of international travel per year.

Your primary tasks/responsibilities:

• Support production sites in HU and CN with sterilisation competences,
• Being sterilization resource in SVS projects,
• Validate sterilisation processes for existing products,
• Re-validate existing sterilisation processes for Coloplast products,
• Ensure validity of sterilisation after transfers and material/design changes. 
• Maintain Sterilization related documentation

Your qualifications:

• Preferably a master’s degree in Science, e.g. Pharmacy, Chemistry, Biochemistry, Engineering
• Preferably with 1-3 years of relevant work experience,
• Fluent in English,
• Willingness to travel,
• Positive and result oriented approach,
• Experience from the medical device industry, e.g. within clean room production, change control, audits or similar,
• Knowledge of relevant standards ISO9001 / ISO13485, 
• Cooperation and working in project groups as well as independently,
• Systematic thinking,
• High level of professional integrity,
• Able to manage many tasks at the same time

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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