CSV Experte (Distributed Control System)

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