remote
Computer Systems Validation Engineer - CAI
Software Engineer
Lead validation of critical software systems in regulated environments, ensuring GxP compliance through automated testing, documentation, and audit readiness using Python, SQL, and industry best practices.
About the role
Key Responsibilities
- Design, develop, and execute automated validation scripts for FDA‑regulated software using Python and SQL.
- Document validation activities, produce V&V reports, and maintain traceability matrices.
- Collaborate with cross‑functional teams to define validation scope, risk assessments, and acceptance criteria.
- Ensure compliance with GxP, 21 CFR Part 11, and ISO 13485 standards throughout the software lifecycle.
- Lead root cause analysis and corrective action for validation failures, driving continuous improvement.
Requirements
- 3+ years of experience in computer systems validation within regulated industries.
- Proficiency in Python scripting, SQL querying, and test automation frameworks.
- Strong understanding of GxP, FDA regulations, and quality system documentation.
- Excellent analytical, communication, and project management skills.
Skills
pythonsqltest automation