Corporate Sterilization Specialist

ConvaTec Denmark A/S


Corporate Sterilization Specialist

Are you passionate about sterilization and processes? Do you want to join a world leading company specialized in treatment of chronic diseases such as Diabetes and Parkinson’s Disease?

Do you have what it takes to work within prescribed GMP/ISO/GLP standards and to insure compliance to all applicable national and international regulations?Then you might be the right candidate to join our Global Quality Services organization.

We are looking for a Corporate Sterilization Specialist who supports new and existing products and processes performed in a cleanroom manufacturing environment. Position is primarily office environment; however, working in a manufacturing facility clean room which produces medical devices will be required. Visits to contract sterilization units will be required. Use of proper safety equipment is required when in manufacturing or sterilization units.

ConvaTec has 9.400 employees and 310 of these will become your colleagues in Osted, south of Roskilde, approx. 45 minutes' drive from Copenhagen. You will report to the Director, Quality services. We offer you a central role in an exciting company in constant growth. You will work in a dynamic team with international exposure and a multi-cultural organization. Travel days approx. 40 - 60 days yearly.

Main Tasks:

  • Responsible for sterilization duties in the Infusion Care business unit and mentoring/assisting the local SMEs in Infusion Care franchise specific activities.
  • Develops, control and implements systems, procedures, and Business Unit strategies relating to sterilization for the Infusion Care business.
  • Train and mentor local Business Unit sterilization SMEs along with quality, regulatory, manufacturing, and R&D personnel in sterilization concepts, practices, and approaches.
  • Works within prescribed GMP/ISO/GLP Standards and assures compliance to all applicable regulations
  • Provides technical solutions to product development teams and manufacturing using microbiological and sterilization theory and practice
  • Designs, validates and implements sterilization processes taking into consideration sterility assurance, modality compatibility, product and packaging functionality and process compatibility
  • Provides support for manufacturing related sterilization operations, interacting with contract sterilizers and test facilities
  • Provides technical guidance on sterilization needs to Research and Development on new product development
  • Supports manufacturing site environmental control programs by establishing trend reviews, responding to excursions and assessing impact of changes to products, process and environment
  • Assists in conducting technical audits of suppliers, contract manufacturers and laboratories.
  • Participates in internal and external audits as subject matter expert defending sterilization and environmental control processes and activities
  • Delivers results and drives continuous improvement. Sets high performance goals and is accountable for those results


  • BS in Microbiology preferred. BA/BS in appropriate science, mathematics or Engineering accepted, or 5 years or more experience if no appropriate science degree.
  • Demonstrates knowledge of ethylene oxide validation principles and industry standards and experience in sterilization process controls is a must.
  • Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards
  • Have a minimum of three years, preferred five years, hands on experience in designing, validating and implementing sterilization processes and microbial and sterility testing within medical device/pharmaceutical manufacturing.
  • Have a working knowledge of GMP/ISO/GLP guidelines as applied to medical device sterilization
  • Have hands on experience in monitoring and maintenance of validation of controlled environment using current guidelines and regulations
  • Have provision of scientific data to support manufacturing, resolve non-conforming issues and ensure adequate corrective and preventive actions
  • Have general leadership skills to organize complex work schedules
  • Have the ability to work with people and teams in a complex, changing environment and be able to deliver value added results to the business on time
  • Be fully competent in oral and written communications including strong documentation skills

For further information:

Do not hesitate to contact Beau Rollins, Director Quality Services email:

Please send your application/CV before the 6th of April 2020.

ConvaTec, Infusion Care Division (Unomedical a/s) is a global Medical Device company specialized in the treatment of chronic diseases, such as Diabetes Mellitus and Parkinson’s Disease. We develop and market sterile disposable products for subcutaneous infusion of various medications. Our manufacturing facilities in Denmark and Mexico produce more than 100 million infusion sets per year, making us the world leader within this field. Our R&D function with 35 people is situated in Osted, Denmark, making sure that new products meet highest industry standards, satisfy patient needs and comply with applicable regulatory requirements. ConvaTec is on the London Stock Exchange. Further information about the company can be found at our website

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ConvaTec Denmark A/S - hurtigt overblik

ConvaTec Denmark A/S
ConvaTec Denmark A/S
ConvaTec er en global producent af medicotekniske produkter med ledende markedspositioner indenfor stomipleje, sårbehandling, kontinens, intensivbehandling og subkutan infusionsterapi.

Skinderskovvej 32-36
2730 Herlev
Logo: ConvaTec Denmark A/S
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