CSV Engineer — eQMS Validation & Data Integrity

EFOR; Oberwallis; On-site; CHF 110,000 - 140,000; Full time

Job summary

EFOR Group is seeking a CSV Engineer in Visp to support eQMS project validation, ensuring data integrity and regulatory compliance per CFR 21 Part 11 and GAMP5. You will develop validation strategy, create essential documents, and align with GMP standards in a collaborative, on-site team environment.

You will coordinate validation activities, act as the go-to CSV/DI resource, and drive risk-based validation while maintaining timelines and quality.

Qualifications

• Expert in Computer System Validation (CSV) and data integrity.
• Good understanding of GAMP5 and CFR Part 11 requirements.
• Demonstrated knowledge of TrackWise Spring25 or above – QMS Module.
• At least 5 years’ experience leveraging CSV documentation in multidisciplinary project teams.

Responsibilities

• Coordinate validation activities for the eQMS project.
• Act as contact person for CSV/DI questions within the project team.
• Define CSV/DI strategy for the eQMS project.
• Produce validation documents (Validation Plan, FS, DS, FRA, URS, CS, IQ, OQ, PQ etc.).
• Ensure project compliance with GMP and internal SOPs.
• Apply risk-based validation approaches.
• Edit and review change requests, CAPAs and deviations related to CSV/DI.
• Contribute to CSV/DI guidance shaping strategy.
• Ensure overall compliance within the eQMS project.
• Produce documents supporting validation strategy design and execution.

Skills

CSV Expert

GAMP5 & CFR Part 11 knowledge

TrackWise QMS knowledge

5+ years CSV experience

Team collaboration

Agile mindset

Tools

TrackWise Spring25

Job description

EFOR Group is seeking a CSV Engineer in Visp to support eQMS project validation, ensuring data integrity and regulatory compliance per CFR 21 Part 11 and GAMP5. You will develop validation strategy, create essential documents, and align with GMP standards in a collaborative, on-site team environment.

You will coordinate validation activities, act as the go-to CSV/DI resource, and drive risk-based validation while maintaining timelines and quality.