LIMS Specialist

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities.

Where you can make a difference. Where no two days are the same.

Location is onsite in Cincinnati OH

We are looking for an experienced Veeva Application Support Engineer to manage and support Veeva platform applications (Quality, RIM, Clinical, Vault, etc.) deployed across multiple global manufacturing sites and business units.

This role is responsible for ensuring high system availability, regulatory compliance, and a seamless user experience while driving continuous improvement initiatives and supporting global business operations.

• Provide L2/L3 support for Veeva applications across global sites in a 24x5 follow-the-sun support model, as required.
• Troubleshoot and resolve incidents, service requests, and problem tickets within defined SLA timelines.
• Perform root cause analysis (RCA) and implement preventive and corrective actions.
• Monitor system health, performance, availability, and data integrity.

• Support and administer Veeva Vault Quality (QMS, Deviations, CAPA, Change Control), Veeva Vault RIM/Regulatory, and Veeva Clinical/Safety modules, where applicable.
• Manage user access, security, roles, permissions, workflows, lifecycle configurations, document management, and data governance.

• Configure and enhance workflows, forms, business rules, object configurations, metadata, reports, and dashboards.
• Support Veeva release management activities, including impact assessments, sandbox validation, testing, and promotion of changes to production environments.

• Support integrations with SAP ERP, MES/Manufacturing systems, LIMS platforms (e.g., Lab Vantage), and external regulatory systems.
• Manage API integrations, data migrations, interface monitoring, and ensure data consistency and integrity across connected systems.

• Ensure compliance with GxP, GMP, FDA regulations, 21 CFR Part 11, and Annex 11 requirements.
• Support Computer System Validation (CSV) activities, including IQ/OQ/PQ documentation, audit readiness, inspections, audit trail management, and compliance documentation standards.

• Coordinate monthly and quarterly Veeva releases, including impact assessments, regression testing, deployment planning, and production rollouts.
• Participate in Change Advisory Board (CAB) reviews and maintain change control documentation.

• Collaborate with Global Quality, IT, Manufacturing teams, site SMEs across multiple plants, and external Veeva support teams.
• Drive business requirement gathering, solution design, user training, and knowledge transfer activities.

• Identify and implement opportunities for process standardization, workflow automation, and system performance optimization across sites.
• Develop and maintain knowledge base articles, SOPs, user guides, and support documentation.

• Bachelor’s degree in Computer Science, Engineering, Information Technology, Life Sciences, or a related field.
• 5+ years of experience in Veeva application support, administration, and configuration within Pharmaceutical, Biotechnology, or Manufacturing environments.
• Hands‑on experience with Veeva Vault (Quality, Clinical, RIM, Regulatory, or related modules) and strong knowledge of Veeva workflows, life cycles, objects, security, and configuration.
• Experience with cloud-based SaaS platforms, API integrations (REST/SOAP), data migration, validation, reporting, dashboards, and ITSM tools.
• Good understanding of pharmaceutical quality processes (Deviation, CAPA, Change Control, Complaints, Audits) and Life…