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