Computer System Validation (CSV) Engineer in Oberd

  • Salary: 65 - 72 CHF per hour
  • REF Number: 00044743
  • Consultant: Jocelyn Blackham
  • Contact: 01438 842962
  • Date Published: 18.02.2019
  • Closed Date: 08.03.2019
  • Sector:
  • Location: Oberdorf,
  • Discipline:

Computer System Validation (CSV) Engineer - Oberdorf

Jocelyn Blackham is recruiting for a Computer System Validation (CSV) Engineer to join a company in the Medical Device industry at their site based in Oberdorf on a contract basis until the end of 2019.

The successful candidate will be responsible for:

  • Planning and implementing qualification / validation activities and projects of new and existing computer systems according to internal and external requirements for all departments.- Supporting and advising application owners to build and maintain GMP conform systems.
  • Supporting and consulting during projects handling GxP critical computer systems.
  • Planning and implementing of qualification / validation activities and projects of existing computer systems.
  • Performing CSV trainings.
  • Planning, coordinating and executing activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Higher education (Engineer or similar) and background in IT and relevant work experience.
  • Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11.
  • Experience in CSV system development life cycle is required.
  • Background in Quality Systems is required, as the procedures to revise are related directly to the quality of the product or the quality system of the manufacturing.
  • Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
  • Fluent in both English and German.

This is an excellent opportunity to join a leading healthcare company.

For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 772516595 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 44743 in all correspondence.

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