Open position

CSV Engineer – Computer System Validation (GAMP 5)

Computer system validation to GAMP 5: risk-based, focused on data integrity rather than documentation ballast.
Location
Visp, Switzerland (CH)
Workload
Full-time
Contract type
Permanent
Gehaltsspanne
By agreement
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About the role

You validate computerized systems in a GxP environment to GAMP 5: risk-based, with critical thinking and data integrity (ALCOA+) from the outset.

Your responsibilities

  • CSV activities to GAMP 5 (2nd edition), risk-based.
  • Categorisation, supplier assessment and test design.
  • Ensuring data integrity (ALCOA+) across the lifecycle.
  • Change control and periodic review.

Your profile

  • Degree in computer science, engineering, natural sciences or similar.
  • Experience with CSV in a GxP environment.
  • Knowledge of GAMP 5, data integrity and Annex 11.
  • Very good German; English an advantage.

What we offer

  • Demanding projects on real GMP equipment in the life sciences.
  • Short paths, flat hierarchies and real responsibility from day one.
  • Work close to operations rather than from a distance, in a collegial engineering team.
  • Fair, performance-based employment terms and continuing education.
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