Sr. CSVCSAValidation Engineer

7–10+ years of experience in CSV/CSA, Infrastructure & Business Systems Validation. Strong experience supporting GxP computerized systems. Hands-on experience with business separation, acquisition, divestiture, and system transition activities. Ability to independently manage end-to-end validation activities: inventory, assessments, remediation, and final disposition. Strong knowledge of FDA/global regulated environments and GxP standards. Expertise in risk-based validation methodologies. Experience with SaaS/PaaS, cloud applications, infrastructure, and cloud concepts. Strong validation documentation experience including URS/Requirements, Validation Plans, Test Protocols, Traceability Matrix, Test Summary Reports, Validation Reports, SOPs/WIs. Experience reviewing UAT/system test scripts, Design Specifications, Test Plans, and Test Procedures. Strong QA methodology and documentation review/approval experience. Ability to lead/advice junior and senior validation resources. Strong communication, leadership, teamwork, and independent working skills. Experience managing multiple projects/changes with distributed or remote teams. Ability to provide validation guidance, timely reviews, risk escalation, and management support.