Az álláshirdetés lejárt.
Aktuális állást talál az aktív állásajánlatok között: új keresés indítása itt
www.cvonline.hu

Process Engineer (Medical devices - IVD)


  • A hirdetés 939 napja lejárt
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;
Produktion/Operationen;
Projekt/Program-management;
Qualitätswesen;
Naturwissenschaft/Forschung
Veröffentlicht am: 22.09.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1409-15721
Abteilung:Link megjelenítése" width="0" height="0" />
Helyek Külföld
Kategória Külföldi munka
Egyéb hasonló állások Önnek
Polish speaking AR Accountant

HAYS Hungary Kft.

Your new company Our multinational partner is l...
Budapest


Sourcing Specialist

HAYS Hungary Kft.

Your new company Our German multinational pharm...
Budapest


Master Data Services Team Lead

HAYS Hungary Kft.

Master Data Services Team Lead munkatársat kere...
Budapest