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CSV Engineer Qualification and Validation

Our client, a world-leading pharmaceutical company focused on biopharmaceuticals, is looking for a CSV Engineer for a 12-month contract (with possibility for extension) based in Vaud area, Switzerland.

Main Responsibilities:

  • Create, update or review validation documents including Validation plan, testing plan, test scripts for IQ, OQ and PQ and drive execution of verification tests in collaboration with the Project Team.
  • Ensure validation tests performed at core template level are leveraged for site deployment.
  • Compile validation summary reports and ensure all deviations from validation test scripts are properly documented, a rigorous follow up plan is in place to close these deviations properly within defined project timeline.
  • Participate in site compliance enhancement.
  • Write, review, and approve validation documents (examples include plans, specifications, risk analysis, protocols, test scripts, validation reports, deviations, SOPs…).
  • Understand and systematically comply with Annex 11, 21 CFR Part 11, GAMP 5 and cGMP requirements.
  • Excellent written communication and good communication skills to capture business needs, address them through comprehensive validation documentation and SOPs supporting correct use of Computerized Systems.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • 5-10 years’ experience in CSV and Equipment Qualification
  • General Engineer Degree – speciality in Design and Industrialization of mechanical systems
  • Fluent in English and French

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.