Beschreibung
CSV Validation Engineer, German Speaking, CONTRACT, Switzerland
For our large multinational Swiss Medical Devices client in Switzerland, we are currently searching for a German speaking Computer Systems Validation Engineer (CSV) to work in the canton of Solothurn. The CSV validation engineer will cover the part of the GxP-Compliance in the project for various retrospective validations and create the Validation documentation for GxP relevant system elements.
The ideal validation engineer will have in depth knowledge of GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFR, Part 820, Part 11 and national & international regulations and standards associated with the medical device industry. Working experience of computer systems validation for use in a FDA regulated environment is a must.
We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome. Please note there is a job description available on request.
We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.
Kind regards,
Neha Sharma
MBA Michael Bailey Associates
Job Code: 107410
Keywords: Computer Systems Validation engineer, CSV, German, FDA QSR, ISO 13485, ISO 62304, 21 CFR 820, 21 CFR 11, European regulations, Medical devices, GAMP5, GxP, IT, compliance, test methods, Quality, planning, risk Management, documentation, testing, validation, hardware qualification table, FDA, Solothurn, Switzerland
Michael Bailey International is acting as an Employment Business in relation to this vacancy.