Computer system validation engineer (m/f/d) 100%

Schachen, Luzern
Freiberuflich
Vollzeit

16 Tage her

Computer System Validation Engineer (m/f/d)Shape the Future of GMP Validation – One System at a Time

📅 Duration: 6 months (temporary assignment)
📍 Location: Schachen, Switzerland
🔄 Employment type: Temporary

About Our ClientOur client is a globally recognised, innovation-driven company in the biopharmaceutical industry, operating one of Switzerland's leading high-tech development centres near Lucerne. With a strong focus on analytical research, biotechnological development, and clinical-scale manufacturing, the site is embedded in a dynamic international network spanning the US and Ireland. As a Computer System Validation Engineer (m/f/d), you will be part of a team committed to quality, precision, and scientific excellence.Your Responsibilities

Lead and execute qualification activities for analytical instruments and laboratory equipment across the full system lifecycle (procurement, validation, maintenance, upgrades, decommissioning)
Author and manage GMP documentation including SOPs, change controls, deviation investigations, and periodic review documents
Conduct SDLC-based computer system validations in close collaboration with IT and the site's validation unit
Monitor and assess alarm events from controlled-temperature units such as stability chambers and other lab equipment
Coordinate calibration and maintenance schedules together with Laboratory Asset Management Program (LAMP) coordinators to ensure continuous inspection readiness
Provide first-level troubleshooting for analytical instruments (e.g. HPLC, qPCR, plate readers) and support cross-functional teams on site-wide Metrology & Validation initiatives

Your Profile

Background in CSV (Computer System Validation) or Commissioning/Qualification – this is a must-have
Education in biotechnology, pharmaceutical sciences, analytical chemistry, biochemistry, IT, or industrial equipment management – whether via apprenticeship or university degree
Hands-on experience with analytical instruments such as HPLC, qPCR, or assay plate readers
Strong written and spoken communication skills in both English (min. B1) and German (min. B2)
Meticulous documentation skills with a keen eye for detail in a regulated environment
Ability to work independently as well as collaboratively within cross-functional teams, delivering results on time
Experience in a GMP environment, project management, change control, or CAPA management is a distinct advantage

Why nemensis?

Nemensis AG is your specialised recruitment partner in the Life Sciences sector, based in Basel
Comprehensive guidance and support throughout the entire application process by our experienced Consultants
Access to an extensive client network and exciting opportunities across Northwestern Switzerland
Fast and straightforward onboarding through personalised coaching and individual support

Ready to bring your CSV expertise to one of Switzerland's most innovative biopharma sites? We'd love to hear from you! Apply now for the Computer System Validation Engineer (m/f/d) role in Schachen and take your next career step with nemensis.📩 Phill Rogers, Consultant, Phillip.Rogers@nemensis.comNot the right role for you, but you're open to a change? Register with us – we'll reach out to set up an introductory call to understand your goals and match you with the right opportunity.

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