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Validation Engineer

Location Bern, Switzerland
Sector
Job type Permanent
Salary Swiss Franc95000 - Swiss Franc110000 per annum
Start date ASAP
Contact Michael Burgstaller
Job ref ID128076_1594736299

Job description

Wir unterstützen unseren Schweizer Partner dabei für einen Schweizer Kunden einen Validation Engineer zu suchen!

The Client:

An award-winning medical devices company with a focuse on image-guided solutions.

Job Description:

      • Create and maintain the site Master Validation Plan
      • Development of validation protocols (IQ, OQ, PQ)
      • Collate all data associated with a validation (IQ, OQ, PQ) and compile the final validation report for approval
      • Maintain all validation documentation in accordance with site Quality System Requirements
      • Verify that that validation studies have been adequately recorded and documented in accordance with the approved Master Validation Plan(s) and Validation Protocols
      • Ensure that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed
      • Ensure that the validated state is maintained
      • As a Validation Engineer you will be responsible for all relevant Process / Equipment Validation activities
      • Review of the impact of change on the maintenance of the validated state, including execution of re-validation as required
      • Periodic review of documentation management system workflows to ensure both regulatory & business needs are satisfied
      • You will also be expected to contribute to other QA activities such as: NC/CAPA management, Supplier Management, Change Control

The ideal candidate:

      • You are an energetic person with a clear attitude towards progress and success
      • 3-5 years of validation experience in a medical device manufacturing environment
      • Bachelor's degree in Engineering, Manufacturing or related field preferred
      • You are very systematic and have a highly developed common sense
      • You are comfortable in independent decision making
      • Knowledge of medical device regulations and standards such as ISO 13485, GMP 21 CFR, MDR, ISO (production FMEA)
      • Knowledge of statistical techniques, Minitab user knowledge a distinct advantage
      • The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules
      • Proficient in English, German is a plus

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