CSV Specialist (m/f/d)

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 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 is a plus

• Very good German (written & spoken) and good English