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Sterilisation Specialist

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Coloplast

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Location:
Denmark , Humlebæk

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Provide invaluable insight into product sterilisation validation to help ensure product quality globally. Join a highly engaged team operating in a dynamic and professionally challenging working environment, collaborating with a large network of stakeholders and ensuring that QA deliveries meet applicable requirements. Participate in projects across product development and supply value stream, dividing time between daily operations and projects. Up to 20 days of international travel per year.

Job Responsibility:

  • 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 production sites in Denmark, Hungary, China and Costa Rica with sterilisation competencies

Requirements:

  • MSc in e.g. pharmacy, microbiology or engineering and have experience with or an interest in sterilisation by radiation and ethylene oxide
  • Experience in a related field e.g. microbiology or polymer science
  • Knowledge of relevant standards ISO9001/ISO13485 and ideally experience from the medical device industry within quality, design control, change control, audits or similar
  • Knowledge of clean room production
  • Speak and write English fluently
  • Appreciate the importance of setting guidelines and procedures and enjoy taking a highly systematic and detail-oriented approach
  • Highly driven and know how to take ownership of tasks
  • Enjoy working in a dynamic and changing environment
  • Patient and steadfast by nature, can push for results and confidently accept or reject solutions
  • Co-ordination skills enable collaboration with colleagues across levels and functions as well as with suppliers all over the world

Nice to have:

  • Experience in a related field e.g. microbiology or polymer science
  • Knowledge of clean room production

Additional Information:

Job Posted:
March 26, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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