Engineering Specialist – Veeva

Key Responsibilities

• Provide L2/L3 support for Veeva Applications across global sites (24x5 / follow-the-sun model as required)
• Troubleshoot and resolve incidents, service requests, and problem tickets within SLA timelines
• Perform root cause analysis (RCA) and drive preventive actions
• Maintain system health, performance, and data integrity
• Support core Veeva modules such as: Veeva Vault Quality (QMS, Deviations, CAPA, Change Control), Veeva Vault RIM / Regulatory, Veeva Clinical / Safety (if applicable)
• Manage User access & security (roles, permissions), Workflows and lifecycle configurations, Document and data management, Enhancements & Configuration, Workflows, forms, and business rules, Object configurations and metadata, Reports and dashboards
• Support release management (monthly Veeva releases) and impact assessments, Validate changes through sandbox testing and promotion to production
• Support integrations with: ERP systems (SAP), MES / Manufacturing systems, LIMS (LabVantage, etc.), External regulatory systems, Handle API integrations, data migrations, and interface monitoring
• Ensure data consistency and integrity across systems
• Ensure compliance with: GxP, GMP, FDA regulations 21 CFR Part 11 / Annex 11, Support CSV (Computer System Validation) activities: IQ/OQ/PQ documentation, Audit readiness and inspections, Maintain audit trails and documentation standards
• Coordinate Veeva quarterly/monthly releases: Impact assessment, Regression testing, Deployment coordination, Participate in CAB (Change Advisory Board) reviews, Maintain change control documentation
• Drive stakeholder & vendor management: Collaborate with: Global Quality, IT, and Manufacturing teams, Site SMEs across 100+ plants, External vendors (Veeva support), Drive business requirement gathering and solution design, Provide user training and knowledge transfer
• Identify opportunities for: Process standardization across plants, Workflow automation, System performance optimization, Develop and maintain KB articles, SOPs, and user guides