CSV Validation Engineer

Role Overview:

• Senior, hands-on validation role supporting complex technology platforms in pharmaceutical and GxP-regulated environments.
• Lead risk-based computerized system validation across cloud applications, edge devices, and scientific instruments.

Key Responsibilities:

• Develop and execute risk-based validation strategies and deliverables, including plans, protocols, traceability matrices, and summary reports.
• Assess data flows, integrations, and system behavior to ensure data integrity and regulatory compliance.
• Maintain validated state and support audits, deviations, and CAPAs.

Requirements:

• 10+ years of CSV experience in GxP environments with strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and ALCOA+.
• Experience with SaaS, cloud platforms, LIMS, MES, ELN, and enterprise integrations.
• Excellent technical writing and cross-functional collaboration skills.

Benefits:

• Senior-level ownership with exposure to complex cloud, edge, and lab environments.
• Remote-friendly culture with professional growth opportunities.