Business System Validation Specialist
Core
Supervise execution of system validation activities to ensure data integrity, regulatory compliance, and operational excellence for data integration and automation solutions supporting clinical and business operations.
Role type
Senior IC business system validation specialist (data integration)
Builds
Validated data integration and automation systems for clinical and business operations
Domain
Life Sciences / Clinical Data Management / GxP Compliance
Required skills
Validation planning and strategy, Test execution (functional, integration, UAT), Defect management and issue resolution, Root cause analysis (RCA) and CAPA, Validation documentation (Test Plans, RTMs, Scripts), Compliance standards (GxP, 21 CFR Part 11), Clinical data management systems, Cloud computing platforms, SDLC management, Metrics and reporting tools
Preferred skills
AI testing and automation frameworks, Power BI
Technologies
Clinical data management systems, Data integration environments, Cloud computing platforms, Power BI
Responsibilities
Execute standard and study-specific validation activities, Create validation strategies and risk-based test coverage models, Monitor test execution and track defects, Perform detailed test execution for functional, integration, and UAT, Participate in root cause analysis and contribute to CAPA recommendations, Ensure accuracy and inspection readiness of validation packages, Support system readiness assessments, Assist in internal and external audits/inspections
Seniority
Mid-level, hands-on IC