CSV Engineer — eQMS & Data Integrity Specialist

EFOR

Oberwallis

On-site

CHF 110,000 - 150,000

Full time

13 hours ago

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Job summary

EFOR Group in Visp, Switzerland, is seeking a CSV Engineer for an on-site role to support eQMS validation from a CSV perspective. The role emphasizes adherence to CFR Part 11, GAMP5, and Data Integrity, with responsibilities across validation planning, execution, and documentation within a TrackWise-based environment.

Applicants should have at least 5 years of CSV experience in multidisciplinary teams, a proactive approach, and strong teamwork.

Qualifications

Expert in CSV and computer system validation.
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.
Strong team-oriented mindset and organized working style.
Agile, proactive problem-solving approach.

Responsibilities

Coordinating the validation activities for the eQMS Project.
Acting as contact person for CSV/DI questions within the project team.
Defining the CSV/DI strategy for the eQMS Project.
Producing validation documents (Validation Plan, FS, DS, FRA, URS, CS, IQ, OQ, PQ etc.).
Ensuring compliance with GMP standards and internal SOPs on CSV and Data Integrity.
Applying risk-based validation approaches.
Editing and reviewing change requests, CAPAs and deviations related to CSV/DI.
Contributing to CSV/DI guidance to influence strategy.
Producing all necessary documents to support validation strategy design and execution.