US_East | Product / System & PLM Engineer_L2

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
• 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

Requirements

Experience with Veeva Vault and related applications is essential.

Strong troubleshooting and problem-solving skills are required.

Excellent communication and collaboration skills are necessary.

Ability to work independently and as part of a team is important.

Knowledge of regulatory requirements and compliance processes is beneficial.

Experience with API integrations and data migrations is advantageous.

Proficiency in Microsoft Office and Veeva tools is preferred.

Qualifications

BS/BA degree in Computer Science, Information Technology, or a related field.

Minimum of 5 years of experience in Veeva Application Support or similar roles.

Experience with Veeva Quality, RIM, Clinical, and Vault modules is highly desirable.

Experience with Veeva release management and impact assessments is advantageous.

Experience with Veeva integration and data management is beneficial.

Experience with Veeva compliance and validation processes is helpful.

Skills

• Veeva Vault and related applications
• System troubleshooting and problem-solving
• Communication and collaboration
• Independent and team-oriented work style
• Regulatory compliance and process standardization
• API integrations and data migrations
• Microsoft Office and Veeva tools proficiency