CSV Validation Engineer

📋 Description

• Lead risk-based computerized system validation across cloud apps, edge devices, scientific
• Develop and execute validation plans, requirements, risk assessments, test protocols, and
• Ensure regulatory compliance with ALCOA+ and data-integrity principles; maintain traceability of
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers to review
• Prepare validation packages for audits, inspections, and supplier assessments; support corrective
• Establish practical, modern validation practices while maturing processes in a growing organization.

🎯 Requirements

• 10+ years of computerized system validation in pharmaceutical/biotech/GxP environments.
• Strong 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 with user requirements, risk assessments, validation plans, protocols, traceability
• Experience validating configurable software, SaaS, cloud platforms, labs, manufacturing, or
• Familiarity with electronic records/signatures, audit trails, access controls, security, data

🎁 Benefits

• Senior-level opportunity with ownership across validation and regulated platforms.
• Exposure to complex cloud, edge, lab, manufacturing, API, and instrument environments.
• Influence validation processes within a growing organization.
• Remote-friendly environment with autonomy and responsibility.
• Apply modern risk-based validation and Computer Software Assurance practices.
• Professional growth through exposure to evolving technologies and regulatory requirements.