• Participate in RTSM requirement gathering sessions with clients and RTSM team members • Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format • Ensure requirements are adequately tested following a risk-based approach • Develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices • Manage Validation testing cycles and resolution of issues and enhancement requests • Maintain change control documentation to ensure ongoing validation of the RTSM system • Provide technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements • Support customers as needed in RTSM validation activities