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.
The ideal candidate
Possess extensive experience as a CSV expert with in-depth knowledge of process control systems (PCS) in a pharmaceutical GMP environment. Demonstrable experience in creating validation-compliant URS, specifications (GxP/CSV), and test plans, as well as experience in using electronic documentation and workflow tools (eVAL) for validation, is essential.
Tasks & Responsibilities:
- 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.
Must-haves:
- 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-haves:
- Experience as a project manager of digitalization projects in a pharmaceutical GMP environment.
Sounds interesting? Apply now – we’re looking forward to receiving your applications!
Application Submission Deadline: 21.05.2026
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