QC Systems Engineer IV (LabVantage LIMS)

About the role

The Quality Control Systems Engineer will work closely with Quality Control (QC), Digital, and Quality/CSV to ensure the reliable, compliant operation of critical laboratory applications and data acquisition systems. This role will act as a senior technical contributor and delivery lead for LabVantage LIMS/LES, with additional responsibility supporting systems such as Empower, Moda, and Novatek. The Engineer will lead projects to enhance system functionality, enable new business capabilities, and maintain audit readiness in LabVantage and will own development activities from custom design and build to testing. The position requires deep LabVantage expertise, cross-functional leadership, and the ability to design compliant solutions in a GxP-regulated environment in partnership with Quality. Position Summary & Responsibilities Serve as senior LabVantage technical subject matter expert for project execution and system enhancements, responsible for configuration, deployment, validation, adoption, and troubleshooting of LabVantage modules. Lead and manage enhancement projects to expand or upgrade QC applications, including rollouts of new LabVantage modules and development of reports and labels. Partner with scientific business stakeholders (e.g., QC) to gather and document user requirements and create actionable application designs and implementation plans. Provide troubleshooting and guidance for LabVantage issues and complex configurations. Support system integrations and assist in architecting solutions to enable secure and reliable data flow across applications. Serve as system support for QC applications, managing user accounts, access rights, roles, and privileges. Ensure reliable, compliant operation of critical QC systems. Manage change controls, deviations, and related records in the electronic Quality Management System (eQMS) for QC system projects. Partner with Quality and CSV to ensure regulatory compliance. Own and execute GxP validation activities for projects and system enhancements. Develop and maintain validation and system lifecycle documentation (e.g., SRS, specifications, IQ/OQ/PQ testing, SOPs). Maintain compliance and audit readiness of assigned systems, ensuring adherence to 21 CFR Part 11 and other regulatory standards.