CSV Validation Engineer

📋 Description

• Lead risk-based validation across cloud apps, edge devices, APIs, and integrations.
• Develop and execute validation strategies for new systems and releases.
• Ensure traceability of requirements, risks, tests, and evidence.
• Collaborate with Engineering, Product, Quality, and Operations teams.
• Support inspection-ready validation documentation and audits.

🎯 Requirements

• 10+ years in computerized system validation in GxP settings.
• Practical knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, GAMP5, ALCOA+.
• Risk-based validation and Computer Software Assurance experience.
• Hands-on with user requirements, risk assessments, plans, protocols, matrices.
• Experience validating configurable software, SaaS, cloud platforms, LIMS/MES/ELN/QMS.
• Understanding of electronic records, signatures, audit trails, data migration.

🎁 Benefits

• Senior-level ownership across validation and platforms.
• Exposure to cloud, edge, lab, and API environments.
• Opportunity to strengthen validation practices in growing orgs.
• Remote-friendly with autonomy and responsibility.
• Grow professionally with evolving regulatory use cases.