<p>For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a CSV Expert (Synthetic Molecule Facility).</p><p>General Information:</p><ul><li>Start Date: ASAP</li><li>Latest possible start date: 01.08.2026</li><li>Planned Employment Duration: 12 months with the possibility of extension</li><li>Workplace: Basel</li><li>Home Office: No</li><li>Workload: 40-60%</li><li>Team: 10 people</li><li>Traveling: No</li><li>Department: Basel Site Services Chapter G10 (EFHCAH)</li><li>Working Hours: Standard</li></ul><p>About the job:</p><p>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.</p><p>The ideal candidate</p><p>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.</p><p>Tasks & Responsibilities:</p><ul><li>CSV Documentation: Leading the creation of validation-compliant User Requirements Specifications (URS) and Functional Specifications (FS) in accordance with GxP/CSV guidelines.</li><li>Solution's & Compliance: Ensuring that the implementation of validation activities for the process control system meets CSV requirements.</li><li>Execution Planning: Creating a roadmap and a detailed schedule for execution and validation.</li><li>Monitoring of execution: Ensuring that the requirements are implemented to the required quality, within the specified timelines and in compliance with CSV standards.</li><li>Interface: Act as coordinator between Technical Compliance and the implementation teams.</li></ul><p>Must-haves:</p><ul><li>Education/degree ideally as an automation engineer or comparable qualification</li><li>At least 10 years of experience in CSV (Computerized System Validation) in a pharmaceutical GMP environment</li><li>Demonstrable experience with process control systems (PCS) or similar automation systems in production</li><li>Demonstrable experience in creating validation-compliant URS and specifications (GxP / CSV)</li><li>Very good IT/tool skills, especially regarding documentation and workflow tools for validation</li><li>English (good knowledge)</li></ul><p>Nice-to-haves:</p><ul><li>Experience as a project manager of digitalization projects in a pharmaceutical GMP environment.</li></ul><p>Sounds interesting? Apply now – we’re looking forward to receiving your applications!</p><p>Application Submission Deadline: 21.05.2026</p>