CSV Engineer

Job Title : CSV Engineer

Job Description :

We are seeking a CSV (Computer System Validation) Engineer with experience in the medical device industry for a long-term onsite contract role in Vernon Hills, IL. The ideal candidate will have a solid understanding of CSV processes, FDA 21 CFR Part 11 compliance, and validation documentation. This role requires hands-on experience with validation activities, ensuring compliance with regulatory requirements, and supporting software validation efforts.

Key Responsibilities :

• Develop and execute Computer System Validation (CSV) protocols, including IQ, OQ, and PQ.
• Ensure compliance with FDA 21 CFR Part 11, GxP regulations, and industry best practices.
• Support validation efforts related to software applications used in a medical device environment.
• Create and review validation documentation, including validation plans, test scripts, and reports.
• Work closely with cross-functional teams, including Quality Assurance, Regulatory, and IT, to ensure compliance with validation requirements.
• Conduct risk assessments and impact analyses for software and computerized systems.
• Support audits and regulatory inspections related to computer system validation.
• Troubleshoot and resolve validation-related issues, providing recommendations for process improvements.

Qualifications :

Preferred Qualifications :