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West Chester Township, Ohio, United States
Onsite
A career at Resilience is more than just a job – it’s an opportunity to change the future.
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.
For more information, please visit www.resilience.com
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 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.
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 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 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).
Sponsorship or support for work authorization, including visas, is not available for this position.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $90,000.00 - $153,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.