CSV Engineer (GAMP 5)

Vispact; Schweiz; Hybrid; EUR 96.000 - 138.000; Vollzeit

Benefits dieser Stelle

Challenging GMP projects

Flat hierarchies

Hands-on responsibility from day one

Continuing education

Confidential application process

Zusammenfassung

Vispact, a life sciences engineering firm, seeks a CSV specialist to validate computerized systems in a GxP environment, focusing on data integrity from the outset. You’ll apply GAMP 5 (2nd edition) with risk-based reasoning and contribute to lifecycle data integrity (ALCOA+).

Responsibilities include CSV activities to GAMP 5, risk-based categorisation, supplier assessment, test design, and change control with periodic review. German proficiency is essential; English is a plus.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Risk-based thinking

Data integrity (ALCOA+)

GAMP 5 knowledge

German language

English language

Ausbildung

Degree in computer science, engineering, natural sciences or similar

Jobbeschreibung

Computer system validation to GAMP 5: risk-based, focused on data integrity rather than documentation ballast.

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.
• Strictly confidential. We treat your application in strict confidence. Without your consent, nobody finds out, not even a client.
• A conversation between engineers. The technical interview is an exchange between equals: no assessment, no standard questions.
• Straight to the founder. Your application goes straight to the founder, not into a portal.

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