Hands-on experience with Computer Systems Validation (CSV) activities, including authoring, reviewing, or executing: Validation Plans (VP)User Requirements Specifications (URS)Functional and Design SpecificationsTest Plans, Test Scripts, and Traceability MatricesValidation Summary Reports (VSR)Strong working knowledge of GAMP 5 guidance, risk-based validation approaches, and lifecycle documentation expectations. Qualifications 2–5+ years of experience in clinical software product quality assurance, test engineering, or validation within government, federal contracting, or regulated industries (e.g., life sciences, healthcare, clinical research).Demonstrated experience applying GxP principles across the full system life cycle, including requirements definition, design qualification, development oversight, testing, deployment, and maintenance.