CSV Validation Engineer

📋 Description

• Lead risk-based validation for complex technology platforms in regulated environments.
• Develop and execute CSV deliverables across cloud apps, edge devices, APIs, and enterprise
• Translate requirements into objective, testable acceptance criteria with traceability.
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers.
• Provide inspection-ready evidence and documentation for audits and regulatory inspections.

🎯 Requirements

• 10+ years of computerized system validation in GxP-regulated settings.
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+.
• Experience with risk-based validation and Computer Software Assurance.
• Hands-on in creating URs, risk assessments, validation plans, protocols, traceability matrices
• Experience validating configurable software, SaaS, cloud platforms, and integrated environments.
• Strong understanding of electronic records, signatures, audit trails, access controls, and data

🎁 Benefits

• Senior-level opportunity with ownership across validation and regulated platforms.
• Exposure to complex cloud/edge/lab/manufacturing/API environments.
• Opportunity to mature validation practices in a growing organization.
• Remote-friendly environment with autonomy and collaboration across teams.
• Apply modern risk-based validation and Computer Software Assurance.
• Professional growth with evolving tech and regulatory use cases.