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Csv Experte (distributed control system)

Switzerland, Basel · Job Posted May 19, 2026
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Job Description

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a CSV Expert (Synthetic Molecule Facility). General Information: Start Date: ASAP, Latest possible start date: 01.08.2026, Planned Employment Duration: 12 months with the possibility of extension, Workplace: Basel, Home Office: No, Workload: 40-60%, Team: 10 people, Traveling: No, Department: Basel Site Services Chapter G10 (EFHCAH), Working Hours: Standard. About the job: The "Synthetic Molecule Clinical and Launch Facility" (SMF) project involves modernizing the existing development and commercial launch production for drug-substance small molecules. The production control systems planned within the Synthetic Molecules Facility (SMF) project are to be qualified/validated according to CSV.

Job Responsibility

  • CSV Documentation: Leading the creation of validation-compliant User Requirements Specifications (URS) and Functional Specifications (FS) in accordance with GxP/CSV guidelines
  • Solution's & Compliance: Ensuring that the implementation of validation activities for the process control system meets CSV requirements
  • Execution Planning: Creating a roadmap and a detailed schedule for execution and validation
  • Monitoring of execution: Ensuring that the requirements are implemented to the required quality, within the specified timelines and in compliance with CSV standards
  • Interface: Act as coordinator between Technical Compliance and the implementation teams

Requirements

  • Education/degree ideally as an automation engineer or comparable qualification
  • At least 10 years of experience in CSV (Computerized System Validation) in a pharmaceutical GMP environment
  • Demonstrable experience with process control systems (PCS) or similar automation systems in production
  • Demonstrable experience in creating validation-compliant URS and specifications (GxP / CSV)
  • Very good IT/tool skills, especially regarding documentation and workflow tools for validation
  • English (good knowledge)

Nice to have

Experience as a project manager of digitalization projects in a pharmaceutical GMP environment

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