CSV Validation Engineer

📋 Description

• Lead risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Develop and execute CSV deliverables: validation plans, requirements, risk assessments, test
• Ensure traceability of requirements, risks, tests, defects, and evidence throughout validation
• Assess data flows, transformations, mappings, and recovery behavior to prevent data loss or
• Evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+ data

🎯 Requirements

• 10+ years of computerized system validation in pharmaceutical, biotech, life sciences, or GxP
• Strong knowledge of Part 11, Annex 11, PIC/S GMP, GAMP 5, ALCOA+.
• Experience with risk-based validation, CSAs, and end-to-end CSV activities.
• Hands-on with user requirements, risk assessments, validation plans, protocols, and traceability
• Experience validating configurable software, SaaS, cloud platforms, laboratory/manufacturing
• Understanding of electronic records, electronic signatures, audit trails, access controls

🎁 Benefits

• Senior-level opportunity with ownership across validated technology platforms.
• Remote-friendly environment with cross-functional collaboration.
• Opportunity to apply modern risk-based validation and CSAs.
• Professional growth through exposure to evolving technologies and regulatory requirements.
• Impact on reliability, compliance, and audit readiness of mission-critical systems.