Software Validation Engineer

Job Summary

To support a short-term project in a regulated environment, the part-time Software Validation & Data Security Engineer will perform hands-on validation and verification of software solutions, focusing on data integrity, security testing, and compliance with regulatory standards.

Key responsibilities

• Conduct software validation and verification testing, including functional testing and data integrity validation
• Develop and execute validation plans, test cases, and protocols while documenting findings and supporting evidence
• Analyze structured datasets and perform technical analysis to ensure compliance with FDA and HIPAA requirements

Required qualifications

• Experience in software validation, QA, IV&V, or computer system validation (CSV)
• Hands-on experience with functional software testing and developing IQ, OQ, and PQ protocols
• Knowledge of FDA 21 CFR Part 11 and HIPAA regulations
• Proficiency in Python and/or SQL for data analysis and automated testing
• Ability to work with large datasets including CSV, JSON, and databases