CSV Engineer

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Senior Consultant- Key Account Management (Contract)

We are supporting a leading pharmaceutical partner in the search for a Computer System Validation (CSV) Subject Matter Expert to join their team on an initial 6-month contract, with strong potential for extension. This position is based in Visp and offers a hybrid working model.

The Role:

You will provide CSV expertise across Production, Quality Control, and IT domains, supporting critical systems such as eQMS, LIMS, and ERP. Working cross-functionally, you will ensure that all computerized systems are validated in line with GAMP 5, Annex 11, 21 CFR Part 11, and data integrity requirements.

Key Responsibilities:

• Lead and support the development of validation deliverables (URS, FS, risk assessments, validation plans, IQ/OQ/PQ protocols, reports)
• Provide subject matter expertise during system design, implementation, and lifecycle management
• Review and analyze executed tests to ensure compliance with predefined acceptance criteria
• Support audits and inspections by preparing relevant documentation and ensuring system readiness
• Identify areas for process improvement and support ongoing system upgrades and enhancements
• Collaborate with Process Owners, System Owners, and external vendors to align on validation strategy and execution

Your Profile:

• 10+ years’ experience in CSV within GxP environments (Production and Lab)
• Deep understanding of GAMP 5, data integrity principles, and regulatory guidelines
• Experience with ERP, MES, LIMS, eQMS, or other GMP-critical systems
• Proven ability to lead validation workstreams and act as SME during audits
• Strong written and verbal communication in English; German proficiency is a plus
• Based in Switzerland or able to commute to Visp for hybrid working

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Temporary

Job function

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Practices

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