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Process Engineer (Medical devices - IVD)

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For one of our partners, a biotechnology company based in French-speaking Switzerland, Kelly Scientific is looking for a Process Engineer.

Your tasks:
• Act as the primary interface between the development team, manufacturing system development partner and manufacturing team
• Develop a clear understanding of the consumable manufacturing process and be able to advise the development partner on all critical to quality aspects of the assay
• Provide expertise on process design, development, and validation
• Develop in conjunction with the Quality and Regulatory Affairs team, a quality control system for the consumable manufacturing system and a validation plan in and to assist with generation of data required for regulatory submissions
• Ensure all critical to quality parameters of assay consumable are built into the manufacturing system and that a robust manufacturing control system is developed
• Ensure a full technology transfer from the manufacturing system development partner
• Interpret critical to quality parameters and ensure that these are incorporated into the manufacturing system design
• Utilise statistical techniques to develop a manufacturing process control system to assure high quality while maintaining the required production volumes
• Establish and maintain the required documentation (e.g. IQ/OQ/PQ) in assigned scope of process
• Assist with the development of a facility and resource plan to ensure target production volumes can be achieved
• Participate in the team to complete the technology transfer from the development partner to the production location.
• Conduct all duties in compliance with Good Manufacturing Practice (GMP) and regulatory requirements.
• Attend internal/external meetings and courses as appropriate and disseminate information to the development project teams (significant travel during the validation phase)

Your profile
• EPF/HES Engineering Micro Engineering /Electronics, Science degree essential
• Experience in IVD development or manufacturing
• 6 Sigma Green/Black belt, an advantage
• Lean principles knowledge, a plus
• Fluent in English, mandatory
• Team player, effective communicator

Should your profile match our requirements, please contact:
Marina Leroy - PhD in Biology - Scientific Recruitment Consultant
Kelly Scientific - Geneva

Region: Vaud
Vertragsart: Dauerhaft
Kategorie: Ingenieurwesen/Entwicklung/Konstruktion;
Veröffentlicht am: 22.09.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1409-15721
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