Senior CSV Specialist

H2B Group is a consulting company supporting clients in business process automation using AI and helping IT specialists develop their careers in the B2B model. The company offers projects in sectors including fintech, medtech, edutech, and industrial automation. The client runs an advanced technological project in the pharmaceutical and medical sectors with high regulatory rigor, aiming to prepare a complete audit-ready validation documentation package following a specification-first approach.

• Minimum 7 years of professional experience.
• Documented experience in Computerised System Validation (CSV) in the pharmaceutical industry.
• Proficient knowledge of the GAMP 5 standard.
• Practical experience creating validation specifications and documentation: URS, FS, DS, and conducting IQ, OQ, PQ.
• Experience with processes: risk assessment, requirements traceability, change control, and periodic review.
• Fluent use of AI coding agents or willingness to master them within two weeks.
• Very good written English skills at regulatory level.
• Availability to work in a hybrid model in Warsaw (1–2 days per week initially, with option for remote work).

Nice to have:

• Experience with Veeva QualityDocs system.

• Full responsibility for the GxP validation package (~20 documents) ensuring audit readiness.
• Classification of validation documents into narrative and state-derived categories.
• Creation and supervision of narrative documentation.
• Management of risk assessment, requirements traceability, change control, and periodic reviews.
• Collaboration with the Platform Owner responsible for architecture.
• Preparation of precise English documentation meeting auditor standards.

Data administrator is H2B Group Sp. z o.o. with GDPR data processing information and candidate rights detailed as per legal requirements.