QC Systems Engineer IV; LabVantage LIMS

Position: QC Systems Engineer IV (LabVantage LIMS)
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Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

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Summary

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 Lab Vantage 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 Lab Vantage and will own development activities from custom design and build to testing. The position requires deep Lab Vantage 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 Lab Vantage technical subject matter expert for project execution and system enhancements, responsible for configuration, deployment, validation, adoption, and troubleshooting of Lab Vantage modules.

* Lead and manage enhancement projects to expand or upgrade QC applications, including rollouts of new Lab Vantage 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 Lab Vantage 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.

Minimum Qualifications

* Experience developing and maintaining Lab Vantage reports preferably using Jaspersoft Studio.

* Extensive experience maintaining Lab Vantage LIMS in biotech, pharma, or life sciences.

* Experience developing and maintaining label printing solutions, preferably in Bar Tender.

* 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 Lab Vantage architecture, including JBOSS, Microsoft SQL Server, and/or Apache or other applicable program.

* 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 Lab Vantage 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 Lab Vantage Work Assignment and Planning module.

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