CSV Specialist - Remote

Overview

The Quality System Support group of the ITOT Basel department is responsible for ensuring validation and compliance of computerized laboratory systems in the QC Basel/Kaiseraugst and MSAT Kaiseraugst laboratories, in line with Good Manufacturing Practice (GMP) requirements.

In Short

• Validate computerized systems in compliance with relevant guidelines, SOPs, and testing requirements.
• Perform CSV Performance Qualifications (PQs) for validated or qualified laboratory systems.
• Conduct or support periodic reviews and user controls for validated or qualified laboratory systems.
• Create GMP-compliant validation documents using eVAL Roche and Veeva systems.
• Support implementation of system changes and manage planning events in Veeva.
• Assist system managers in the evaluation and validation of new systems.
• Draft and maintain GMP documentation, including concepts, SOPs, and work instructions within the scope of responsibility.

Requirements

• Completed vocational training or degree as a technician/engineer in automation, electrical engineering, technical computer science, or laboratory-related discipline.
• 3–5 years of professional experience in Computer System Validation (CSV), including validation of computer-aided systems, periodic reviews, and user controls.
• Initial hands-on experience in a laboratory environment.
• 3–5 years of professional experience in a GMP-regulated environment.
• Reliable, structured, and proactive way of working.
• Strong organizational and analytical thinking skills.
• Proficient IT skills in MS Office; basic knowledge of Veeva and eVAL Roche is a plus.
• Very good German (written & spoken) and good English.

Benefits

• Contract length: 1 year (temporary, extension possible).
• Workload: 100% (up to 40% home office possible by arrangement).
• Start date: ASAP (latest possible: 01.12.2025).