CSV Validation Engineer

📋 Description

• Lead risk-based validated CSV across complex tech platforms
• Develop/test validation plans and evidence packages
• Translate requirements into objective acceptance criteria
• Validate ecosystems: cloud apps, APIs, databases, instruments
• Assess data flows and recoveries to prevent data issues
• Ensure compliance with GxP regulatory expectations

🎯 Requirements

• 10+ years in computerized system validation in GxP env
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5
• Experience applying risk-based validation and CSA approaches
• Hands-on with URs, risk assessments, validation plans, IQ/OQ/PQ docs
• Experience with configurable software, SaaS, cloud, lab/manufacturing systems
• Ability to review architectures, data flows, APIs, and evidence

🎁 Benefits

• Senior-level ownership of validation across platforms
• Exposure to cloud, edge, lab, API, and instruments
• Influence validation processes in a growing org
• Remote-friendly environment with autonomy
• Apply modern risk-based validation and CSA practices
• Professional growth with evolving tech and regs