• Contract
  • Suisse Romande
  • Recruiter: Solette Rhodes

The Life Science Career Network CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

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 

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.