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Engineering and Qualification Expert

vor 1 Woche

Bern, Bern, Schweiz Techfirm Industrial Services Vollzeit
Job Summary

We are seeking a highly motivated and experienced QA & Validation Engineer to join our team in Switzerland. As a Quality Assurance and Validation Lead, you will be responsible for ensuring the quality compliance of all elements leading to commissioning and qualification activities.

The role will provide Quality oversight on both systems and execution of commissioning and qualification, cleaning and process validation and approving respecting documents.

  • Ensures as QA representative the Quality compliance of all elements (e.g. URS, QRA) leading to commissioning and qualification activities (DQ, IQ, OQ and PQ).
  • Review and approve C&Q system specific documentation URS, RTM, QRA, IOC – if applicable, IQ, OQ, PQ, QR according to internal standards.
  • Assess and review Punches, Project Deviations occurred on assigned Systems during C&Q Phase.
  • Assess and review Deviations and Changes occurred during initial validation activities in the Start-Up Phase.
  • Establish Guidance Documents (SOPs, WIs etc) based on request covering Commissioning and Qualification Cleaning and Process Validation.
  • GMP knowledge and knowledge of regulatory requirements.
  • Qualification and Validation experience at a minimum of 3 years in a similar role, preferably gained in a Life Sciences / Pharma / Biotech Upstream / Downstream facility.
  • Several years (at a minimum 3 years) of successful commissioning and/or qualification experience on mid-sized and major projects with high complexity in the chemical, biotech, or pharmaceutical industry.
  • Proven experience in cGMP, Commissioning & Qualification as well as Cleaning and Process Validation and Quality Risk Management.
  • Language: Fluent in English and preferably in German required.