Are you interested in working for a company that is passionate about its customers? That lives its values and nurtures its employees? Then Medela is the company for you.
Founded in 1961 by Olle Larsson and headquartered in Switzerland, Medela today is led by his son Michael Larsson. Medela concentrates on two business units: "Human Milk", with basic research recognised globally and leading in the development and manufacture of breastfeeding products and solutions, and "Healthcare", engineering and manufacturing highly innovative medical vacuum technology solutions. Medela has 19 subsidiaries in Europe, North America and Asia, distributes its products in over 100 countries and employs over 1,600 staff worldwide.
At our headquarters in Baar, we are seeking for the Operations Department a
Sterilization Validation Engineer (m/f) 100%
Your responsibilities
SME Subject Matter Expert responsible for the sterilization process for medical devices by planning, advising, reviewing and compiling appropriate documents
Planning and supervision of the validation and re-validation of the current sterilization process
Monitoring and evaluation of the microbial properties of medical devices, production processes and environmental conditions of the manufacturer/supplier
Cooperation and coordination with internal and external partners
Collaborate with the manufacturer, contract sterilizers, testing laboratories and notified bodies to maintain compliance
Participation in risk analyses and in the development of technical concepts
Responsibility for maintenance activities and plant qualification
Support in evaluation and cooperation with external laboratories
Support auditor for manufacturers, testing laboratories and sterilization service providers
Identification of optimization potential and development of solution approaches
Monthly Review / Data Analysis and Trends of Bioburden Tests
Your qualifications
Bachelor’s degree in Biology, Biotechnology, Microbiology or equivalent
Minimum 5 years' experience in sterile medical device environment
In depth knowledge of industrial sterilization methods and their validation (i.e. EtO and Radiation)
Strong computer skills, including the MS Office suite and MS Project
Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents
Experience associated with continuous improvement activities, including participation and/or facilitating Kaizen events using lean manufacturing principles
Your opportunity
At Medela, you will be joining a global community of colleagues, united by the purpose that drives our business: helping people. Medela exists to advance human health and wellbeing through knowledge-based and innovative human milk and medical vacuum solutions.
Our employees are empowered to serve this purpose in a family-owned company that is growing rapidly around the world. We value intensive exchanges, diverse perspectives, and unbureaucratic decisions. You will have the opportunity to develop at an international level, and witness the direct impact your work has on our company’s success.
If you are interested in this opportunity, Diana Krnja, Head of Recruiting, is looking forward to receiving your application.
For this position we only consider direct applications - thank you for your understanding.
