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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