Veeva LIMS SME Consultant​/Lead Information Systems Engineer Indianapolis

6487 - Veeva LIMS SME Consultant / Lead Information Systems Engineer

Indianapolis, IN

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise
• 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 Lab Ware, Lab Vantage, 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,…