Process Validation Manager

vor 1 Woche


Baar, Schweiz Medela Medizintechnik GmbH & Co. Handels KG Vollzeit

You are a specialist in the field of sterile packaging and take on exactly this role within Medela. With your technical expertise, you are the first point of contact and ensure that our external partners are compliant with Medela's and international standards in operations. Other exciting topics are also part of your responsibilities. We are looking for an independent person with very good communication skills who likes to contribute ideas for process optimization.

Join Medela and help us turn science into care

This is what you can move
  • Define, control and maintain a Sterile Packaging Validation Master Plan, monitor processes at external suppliers and create validation documentation for sterile packaging processes.
  • Support suppliers during implementation, validation and monitoring of sterile packaging processes.
  • Contribute to general process validation activities acting as an SME and/or leading process validations.
  • Coordinate Technical Changes related to process validations at suppliers; mainly sterile packaging processes.
  • Provide technical advice as an SME to suppliers in cases of deviations or quality events in sterile packaging processes.
  • Be involved in supplier quality audits or audit preparations on request.
  • Support in maintaining technical file documentation for our products related to sterile packaging and process validations.
What you bring along
  • Profound technical expertise in the development and implementation of Sterile Packaging processes and extensive knowledge in international standards related to sterile packaging (ISO 11607).
  • University degree (Bachelor, Master) in a relevant field.
  • Practical know-how in process validation and equipment qualification for regulated industries.
  • Experience working in an environment with global objectives.
  • Creativity and ability for collaboration to increase the performance of the given framework.
  • Strong analytical skills (risk-based) and focus on the essential facets and ability to manage multiple conflicting priorities.
  • Excellent verbal and written communication skills in English, German is an asset.
What we offer you
  • Medela Family: A culture characterized by inclusivity and respect that values and supports every member of our team. Together, we pursue one goal: improving the lives of mothers, babies, and patients by translating science into care.
  • Flexibility: If your role allows for it, you can work in a hybrid model with up to 3 days per week working from home.
  • Growth Opportunities: a range of learning initiatives, both on and off the job.
  • Competitive package: Benefits align with international benchmarks, including extended maternity/paternity leave, insurance, and additional vacation or bridge days.
  • Balance: A variety of activities designed to promote health and well-being.

We focus on the personality and professional skills of our candidates. We reject any form of discrimination and look forward to receiving your application.

The hiring process of this position is supported by the responsible Talent Acquisition Manager Julia Winkler. In case of specific questions please contact us on +41 41 562 1077.

For this recruitment, we will not consider any applications sent through by agencies.

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