CSV Specialist (Analytical Lab Systems)

For our client, a global leading pharmaceutical company in Switzerland, we are looking for a CSV Specialist for Analytical Lab Systems.

General Information:

• Start date: ASAP
• Latest possible start date: 01.12.2025
• Duration: 1 year, with the possibility of extension
• Workplace: Kaiseraugst and Basel
• Workload: 100%
• Home Office: Yes, max 40% by arrangement
• Team: 5 people
• Department: Quality Business Consulting
• Working hours: Standard

The 'Quality System Support' group of the ITOT Basel department is responsible for the validation of the computerized laboratory systems in the laboratories of QC Basel/Kaiseraugst and MSAT in Kaiseraugst, taking into account current Good Manufacturing Practice (GMP) requirements.

In this role, you will ensure that internal guidelines and concepts, as well as regulatory requirements regarding the validation of computerized systems in a GMP environment, are applied and that the computerized analytical systems in Kaiseraugst are validated and operated in accordance with these specifications.

Your Profile:

• Completed vocational training or a degree as a technician, engineer in the field of automation, electrical engineering, computer engineering, or training in a laboratory environment
• At least 3 years of professional experience in CSV.
• Initial professional experience in a laboratory environment and three to five years of professional experience in a GMP-regulated work environment are required.

Tasks & Responsibilities:

• Validation of computer-based systems by observing all relevant guidelines, SOPs, and test specifications
• Conducting CSV-PQs for computer-based, validated, or qualified laboratory systems
• Conducting or supporting periodic reviews and user controls for computer-based, validated, or qualified laboratory systems
• Creation of GMP-compliant documents for the validation documents of CSV systems in the eVAL and Veeva systems
• Participation in the implementation of changes to systems and creation / editing of planning events in Veeva
• Supporting system managers in the evaluation and validation of new systems
• Creation and updating of concepts, work instructions (SOPs) and other relevant GMP documents in the area of responsibility

Must Haves:

• Completed vocational training or studies as a technician, engineer in the field of automation, electrical engineering, computer engineering or training in a laboratory environment
• 3-5 years of professional experience in the field of CSV (validation of computer-aided systems, periodic reviews, user controls)
• Initial professional experience in a laboratory environment
• 3-5 years of professional experience in a GMP environment
• Reliable, structured and proactive way of working
• Good organizational skills and the ability to think in context
• Solid IT knowledge of MS Office applications as well as basic knowledge of Veeva and eVAL
• Very good written and spoken German and good written English

Sounds interesting? Apply now - we're looking forward to receiving your applications!

Application Submission Deadline: 26.08.2025