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 including: 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
• Configure and enhance: 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
• 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

Mandatory Skills

• Education: Bachelor's degree in computer science, Engineering, or related field
• Technical Skills: Hands-on experience with: Veeva Vault (Quality / Clinical / RIM), Strong understanding of: Cloud-based SaaS platforms, Configuration (workflows, objects, lifecycles), Experience with: API integrations (REST/SOAP), Data migration and validation, Reporting tools
• Functional Knowledge: Strong understanding of: Pharma Quality processes (Deviation, CAPA, Change Control), Regulatory requirements, Manufacturing plant operations

Experience Required

• 5+ years of experience in: Veeva application support / administration, Pharma / Manufacturing domain
• Experience supporting large-scale global deployments (50+ sites) preferred

Nice-to-Have

• Experience with: LabVantage