Senior computer system validation (csv) engineer

Role Description

Seeking an experienced Computer System Validation (CSV) professional with expertise in GxP systems, regulatory compliance, risk-based testing, and validation documentation within pharmaceutical and life sciences environments.

Roles & Responsibilities

• Perform computer system validation for GxP systems in compliance with applicable regulatory and quality standards.
• Author and maintain User Requirements Specifications (URS), Functional Specifications (FS), validation plans, test protocols, and final validation reports.
• Support audit and inspection readiness, periodic reviews, access roster reviews, and audit trail reviews.
• Manage deviations, CAPAs, and SOP/policy compliance processes.
• Apply risk-based testing aligned with Computer Software Assurance (CSA) fundamentals.
• Support validation activities involving R&D systems and processes, including clinical, biostatistics, discovery, medical affairs, pharmacovigilance, regulatory affairs, RPA GxP bots, and R&D AI GxP.
• Maintain a high-level understanding of Veeva Vault suites.

Required Skills

• Computer System Validation (CSV) for GxP systems
• 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, and ITIL
• Validation documentation: URS, FS, protocols, plans, and reports
• Risk-based testing and CSA fundamentals
• Audit/inspection readiness and periodic reviews
• Deviation and CAPA management
• Veeva Vault suite knowledge
• R&D and pharmaceutical/life sciences domain knowledge

Qualifications

Education: Bachelor of Science, Bachelor of Technology, or Bachelor’s in Pharmacy.

Experience: 8+ years of overall experience, including at least 5 years in Computer System Validation for GxP systems.