Senior CSV Engineer

Job Summary

A company is looking for a Senior CSV Engineer - Project Lead for a remote contract position.

Key Responsibilities

• Lead and manage end-to-end CSV activities for GxP-regulated systems, focusing on EBR platforms
• Plan, execute, and review validation deliverables including URS, FRS, risk assessments, IQ/OQ/PQ, and validation reports
• Ensure compliance with FDA, GAMP 5, 21 CFR Part 11, and other global regulatory standards

Required Qualifications

• 9-10 years of experience in Computer System Validation (CSV) within GxP-regulated environments
• Hands-on experience with Electronic Batch Record (EBR) systems
• In-depth knowledge of FDA regulations, GAMP 5, and 21 CFR Part 11 compliance
• Proven experience leading validation projects and cross-functional teams