CSV Validation Engineer

📋 Description

• Lead risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Develop and execute validation strategies, validation plans, IQ/OQ/PQ docs, traceability, and
• Translate requirements into testable acceptance criteria; ensure traceability of requirements
• Validate complex technology ecosystems including browser applications, cloud services, APIs
• Assess data flows, mappings, unit conversions, recovery, and failure scenarios to prevent data loss
• Assess compliance with FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+

🎯 Requirements

• 10+ years of computerized system validation in pharmaceutical/biotech/GxP-regulated environments
• Strong practical knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+
• Experience applying risk-based validation and Computer Software Assurance to complex systems.
• Hands-on experience creating user requirements, risk assessments, validation plans, protocols
• Experience validating configurable software, SaaS, cloud platforms, lab/manufacturing systems, or
• Strong understanding of electronic records/signatures, audit trails, access controls, security

🎁 Benefits

• Senior-level opportunity with ownership across CSV and regulated tech platforms.
• Hands-on exposure to complex cloud, edge, lab, manufacturing, API, and scientific-instrument
• Opportunity to influence validation practices in a growing organization.
• Collaboration with cross-functional technical, product, quality, and customer-facing teams.
• Remote-friendly environment with autonomy and responsibility.
• Apply modern risk-based validation and Computer Software Assurance practices.