6487 - Veeva LIMS SME Consultant / Lead Information Systems Engineer

Lead IS Engineer Responsibilities:

• Lead and/or support Veeva LIMS implementation activities from requirements gathering and process design through configuration, integration, testing, deployment, and go-live
• Partner with Laboratory, Quality, IT, Business Process Owners, and other stakeholders to define business requirements, map laboratory workflows, and translate business needs into effective LIMS solutions
• Support Veeva LIMS configuration and system design, including workflows, user roles, master data, specifications, calculations, reporting, and other system functionality.
• Coordinate and support system integrations, interfaces, and data migration activities to ensure successful connectivity with instruments, enterprise applications, and related laboratory systems
• Lead or support functional testing, integration testing, user acceptance testing (UAT), defect management, and issue resolution throughout the implementation lifecycle.
• Facilitate implementation workshops, requirements reviews, design sessions, testing activities, and stakeholder meetings; coordinate actions and drive issues to resolution
• Support deployment, cutover, go-live, and post-implementation stabilization, including troubleshooting, user support, and transition to ongoing system ownership
• Develop and/or review implementation and supporting documentation, including requirements, functional specifications, configuration documentation, test plans/scripts, traceability, SOPs, and implementation/transition documentation
• Apply risk-based CSV/CSA and GxP principles throughout the implementation to ensure the system is appropriately assessed, tested, and fit for intended use
• Support system lifecycle activities following implementation, including change control, enhancements, defect resolution, periodic reviews, and continuous improvement
• Ensure the implementation addresses applicable regulatory and data integrity expectations, including 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles
• Provide technical subject matter expertise and serve as a key liaison between business users, laboratory teams, IT, Quality, vendors, and implementation partners

Job Requirements:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline
• 5+ years of experience supporting LIMS implementations, system implementations, laboratory systems, or related technology projects within pharmaceutical, biotechnology, or other GxP-regulated environments
• Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management
• Experience with Veeva LIMS or other enterprise LIMS platforms such as LabWare, LabVantage, or similar systems
• Demonstrated ability to translate laboratory/business requirements into system functionality, including workflow, configuration, integration, and reporting requirements
• Experience coordinating system integrations, interfaces, data migration, UAT, defect management, deployment, and post-go-live support
• Strong project management, organizational, communication, and problem-solving skills