QC Systems Engineer IV (LabVantage LIMS)

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.

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.

Minimum Qualifications

• Experience developing and maintaining LabVantage reports preferably using Jaspersoft Studio.
• Extensive experience maintaining LabVantage LIMS in biotech, pharma, or life sciences.
• Experience developing and maintaining label printing solutions, preferably in BarTender.
• Strong project leadership experience, including planning and managing multiple concurrent projects.
• Excellent communication skills, with the ability to translate technical concepts for non-technical stakeholders.
• Strong analytical and problem-solving skills, with the ability to independently diagnose and resolve complex system issues.
• Programming experience using SQL.
• Experience with LabVantage architecture, including JBOSS, Microsoft SQL Server, and/or Apache or other applicable programs.
• Experience with GxP validation and understanding of regulatory requirements (e.g., GxP, 21 CFR Part 11).
• Proven experience authoring and maintaining SOPs, validation protocols, and system lifecycle documents.

Preferred Qualifications

• Bachelor’s degree in a scientific, technical, or related discipline.
• 5+ years of experience maintaining LabVantage LIMS in biotech, pharma, or life sciences.
• Experience with system lifecycle management, including upgrades, patches, and periodic reviews.
• Experience with Empower, Moda, Novatek, or other data acquisition systems.
• Experience implementing and supporting LabVantage Work Assignment and Planning module.
• Programming experience using JavaScript and/or Groovy.
• Familiarity with electronic Quality Management Systems (eQMS), such as Veeva.
• Experience designing and supporting integrations with enterprise systems (e.g., ERP, data platforms).