Verista, Inc.

Engineer

• Lead development of the validation strategy within the first 30 days of onboarding
• Oversee CSA/CSV compliance execution aligned with the customer SDLC and quality procedures
• Provide governance, review, and approval of validation lifecycle deliverables (URS, risk assessments, validation plans, specifications, testing artifacts, traceability, and validation summary)
• Ensure readiness for formal testing and completeness of change control documentation
• Support CMDB governance and provide guidance on validation and testing tools
• Monitor KPI adherence including approval cycle time and traceability coverage

Senior CSV Engineer / Senior Validation Engineer

• Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems
• Perform validation of Data Lake platforms and associated system interfaces, including data ingestion, transformation, and reporting layers
• Collaborate with cross-functional teams (IT, QA, Business, Data Engineering) to define validation scope, risk assessments, and acceptance criteria
• Ensure compliance with GxP, 21 CFR Part 11, and data integrity requirements throughout the system lifecycle
• Support deviation investigations, CAPAs, and change control activities related to validated systems
• Maintain validation documentation including Validation Plans, Risk Assessments, Traceability Matrices, and Summary Reports

IT CSV Engineer, Senior Validation Engineer

• Execute CSA and validation activities in accordance with SDLC procedures and quality expectations
• Assist in preparation of validation plans, functional risk assessments, and traceability matrices
• Support review of validation/testing documentation and change control artifacts
• Contribute to validation summary reporting and lifecycle compliance deliverables
• Support change control, configuration management, and release activities
• Collaborate with Digital Quality, System Owners, and Business stakeholders throughout execution

CSA Engineer, Validation Engineer

Product Marketing

• Provide GMP quality oversight and technical support to internal manufacturing operations and contract manufacturers (CMOs), ensuring compliance with Quality Agreements and regulatory requirements
• Support change control activities, including impact assessments, implementation, review, approval, and closure in accordance with established procedures
• Manage and approve deviations, OOS/OOT investigations, and root cause analyses, ensuring appropriate product impact assessments and effective CAPA implementation
• Conduct comprehensive GMP document review, including Master and Executed Batch Records, validation protocols, and summary reports to support batch disposition and on-time release
• Monitor and maintain Quality Metrics, proactively identifying risks and driving mitigation strategies to ensure compliance and operational performance
• Collaborate cross-functionally to support continuous improvement initiatives, strengthen quality systems, and enhance overall GMP compliance

GMP Quality Specialist

Therapist

• Provide end-to-end quality systems oversight for Cell & Gene Therapy platforms, ensuring compliance with global GMP and ATMP regulatory requirements
• Lead comprehensive review and disposition of deviations impacting Cell & Gene programs, ensuring appropriate impact assessments, risk evaluations, and timely resolution
• Drive cross-functional CAPA processes, facilitating structured root cause investigations and ensuring implementation of sustainable, risk-based corrective and preventive actions
• Partner with Quality Operations and QISM teams to evaluate system-level trends, identify recurring risks, and strengthen overall quality system effectiveness
• Oversee lifecycle management and periodic review of SOPs and controlled documents governing Cell & Gene Therapy platforms to ensure alignment with evolving regulatory guidance
• Serve as Quality SME during audits and regulatory inspections, coordinating documentation, responses, and inspection readiness efforts specific to advanced therapy programs
• Ensure robust governance of quality system elements critical to Cell & Gene Therapy
• Monitor and trend quality metrics to proactively identify compliance gaps and drive continuous improvement initiatives across the platform

Senior CSV Engineer / Senior Validation Engineer

IT CSV Engineer, Senior Validation Engineer

CSA Engineer, Validation Engineer

GMP Quality Specialist

Cell & Gene Therapy Quality Lead