Verista, Inc.

Engineer

• Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
• Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
• Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
• Oversee validation readiness and ensure prerequisites are met prior to formal testing
• Support change control, configuration management, and release activities
• Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance
• Provide guidance on CSA-based, risk-driven validation approaches
• Conduct periodic system compliance reviews, validation health checks, and lifecycle assessments to ensure continued validated state and ongoing regulatory compliance.
• Support periodic review activities including user access reviews, audit trail assessments, data integrity evaluations, and system inventory maintenance.
• Assess the compliance impact of deviations, incidents, CAPAs, and system issues, ensuring appropriate remediation and documentation.
• Review and support vendor documentation, supplier assessments, and SaaS provider quality documentation to support risk-based compliance decisions.
• Monitor and evaluate regulatory inspection observations, internal audit findings, and compliance trends to identify opportunities for process improvement.
• Participate in governance forums and compliance review boards, providing CSA guidance for system lifecycle management and ongoing operational support.

Senior Validation Engineer

CSA Consultant – Senior Validation Engineer

Data Analyst

• Provide CSA / CSV subject matter expertise across Data Analytics, AI, Machine Learning, and Digital platforms
• Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
• Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
• Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
• Assess AI/ML solutions and analytics platforms to determine appropriate risk-based assurance activities
• Oversee validation readiness and ensure prerequisites are met prior to formal testing
• Support change control, configuration management, and release activities
• Partner with Quality, System Owners, Data Owners, and Business Process Owners to ensure ongoing compliance
• Provide guidance on CSA-based, risk-driven validation approaches for analytics and AI-enabled solutions
• Support supplier assessments, vendor documentation reviews, and leveraging of vendor testing where appropriate

Senior Validation Engineer

CSA Consultant – Senior Validation Engineer

Lead Validation Engineer, Data Analytics/AI