CSV Specialist

CSV Specialist

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 this role, you will contribute to the validation, operation, and maintenance of computerized analytical systems while ensuring adherence to internal standards and regulatory guidelines. You will collaborate closely with system managers and colleagues to support CSV (Computer System Validation) activities and maintain GMP-compliant documentation.

Location: Kaiseraugst & Basel, Switzerland
Contract length: 1 year (temporary, extension possible)
Start date: ASAP (latest possible: 01.12.2025)
Workload: 100% (up to 40% home office possible by arrangement)
Language requirement: Very good German (written & spoken) and good English

Key Duties & Responsibilities

• 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

Must Haves

• 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