CSV Engineer

BioTalent; Visp; Hybrid; CHF 90’000 - 130’000; Teilzeit

Zusammenfassung

A prominent consultancy in Switzerland is seeking a Senior Consultant for Key Account Management, specializing in Computer System Validation (CSV) within the pharmaceutical sector. The role involves leading validation projects, ensuring compliance with regulatory standards, and collaborating with various stakeholders. Strong expertise in GxP environments and effective communication in English are essential for success in this position.

Qualifikationen

• 10+ years’ experience in CSV within GxP environments.
• Deep understanding of GAMP 5 and data integrity principles.
• Proven ability to lead validation workstreams during audits.

Aufgaben

• Lead and support the development of validation deliverables.
• Provide subject matter expertise during system design and lifecycle management.
• Collaborate with Process Owners and external vendors to align validation strategy.

Kenntnisse

CSV expertise

GxP environments knowledge

Regulatory compliance

Strong communication skills

Jobbeschreibung

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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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