CSV Consultant

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Expertree Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

About the job

At Expertree, transparency is fundamental. Our fixed flat-margin model ensures clarity for both clients and consultants, enabling significantly higher compensation for our experts. Established in 2011, we operate with precision, minimizing administrative burden and streamlining processes to ensure smooth and efficient collaboration. Every consultant is rigorously vetted to guarantee excellence, and our optimized internal structure allows us to offer rates above industry standards while delivering exceptional value to our partners.

Immediate Contract Opportunity: CSV Consultant Switzerland (Basel - Remote)

Duration:

12 months (extension very likely)

We are supporting a global pharmaceutical organization in strengthening their Computer System Validation (CSV) capabilities across manufacturing, quality, and laboratory functions. You will play a key role in ensuring compliance for GxP-critical systems and supporting digital transformation initiatives aligned with regulatory expectations.

Key Responsibilities:


• Execute Computer System Validation activities in compliance with GAMP 5, Annex 11, and 21 CFR Part 11


• Develop and review validation deliverables (URS, FS, DS, IQ/OQ/PQ, validation plans, and reports)


• Support system risk assessments and data integrity evaluations for GxP systems


• Collaborate with QA, IT, and system owners to ensure audit-ready documentation


• Lead deviation investigations, CAPA support, and change control components related to validated systems


• Support validation activities for MES, LIMS, ERP, lab and manufacturing equipment software, or automation systems

Profile Sought:


• Minimum 5 years of experience in CSV in a GxP environment (biotech/pharma strongly preferred)


• Strong knowledge of data integrity principles, GAMP 5, Annex 11, and 21 CFR Part 11 requirements


• Proven experience producing audit-ready validation documentation and managing validation lifecycle activities


• Hands-on experience with at least one major system: MES, LIMS, ERP, SCADA/DCS, lab instrumentation systems


• Strong communication skills and ability to work cross-functionally with QA, IT, and operations teams


• Fluency in English (German or French is a plus)

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