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CSV Engineer 5226 SRS

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Process Automation Engineer for a 6 month contract with high chances of extension based in the Valais area, Switzerland.

We are looking for a CSV Engineer for a contract role until the end of 2023 to work on site. Your extensive experience in automation and 5+ years in commissioning, qualification and validation and fluency in both English and German is essential for this role.

Main Responsibilities:

  • Creating the requested CSV documents according SOP’s
  • Executing the CSV tests
  • Supporting the CSV timelines with PM & CQV-Lead
  • Acting as subject matter expert (SME) on following CQV / CSV standards
  • CSV person of contact of the assigned system for handover to the operation organization
  • Defining with EMR and Package Units vendor the most appropriate design for vertical integration in the company environment
  • Creating the requested CSV documents according company SOP’s and Guidelines
  • Organising the reviews of the CSV documents for last QA approval
  • Participating to the FAT & SAT
  • Creating tests protocols and execute the tests
  • Working in close collaboration with CSV Lead or CQV Lead

Qualifications and Experience: 

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Significant experience in automation
  • Extensive experience in vertical integration and data management under validated computer systems
  • Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable
  • Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs
  • Strong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large and complex projects
  • Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
  • Experience in People Management (internal and external) with respect to organizational aspects, coaching and development
  • Excellent command of English and proven knowledge in German necessary 

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