Senior CSV Specialist (Computerised System Validation)

Quick Facts

• Role: Senior CSV Specialist (Computerised System Validation)
• Work model: Hybrid in Warsaw initially (1–2 days/week in the office), with an option to move to remote
• Focus: GxP validation package readiness for audits

Description

You will take end-to-end responsibility for a GxP validation package (around 20 documents) and ensure full audit readiness in a specification-first approach. The role includes categorizing validation documents, creating and overseeing narrative documentation, and managing core CSV processes such as risk assessment, requirements traceability, change control, and periodic reviews. You will collaborate closely with the Platform Owner and produce precise validation documentation in English according to auditor expectations.

Requirements

• Minimum 7 years of professional experience
• Documented experience in Computerised System Validation (CSV) in the pharmaceutical industry
• Strong knowledge of GAMP 5
• Practical experience creating validation documents (URS, FS, DS) and executing IQ, OQ, PQ
• Experience with Risk assessment, Requirements traceability, Change control, and Periodic review
• Excellent English writing skills (regulatory level)
• Willingness to work hybrid in Warsaw (initially 1–2 days/week), with a potential transition to remote
• Ability to use AI coding agents or readiness to learn them within the first 2 weeks

Benefits

• Remote work flexibility
• Interesting projects matched to your skills and interests
• B2B contract without an exclusivity clause
• Professional development with the latest technologies across diverse projects