Engineer VI – QC Applications
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Job Description
Quality Control Systems Engineer ensuring reliable lab applications at biomanufacturing company Resilience. Leading projects for QC enhancements and system compliance in GxP-regulated environments.
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
Requirements:
- 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.
Benefits:
- robust total rewards program including an annual cash bonus program
- 401(k) plan with a generous company match
- healthcare (including medical, dental and vision)
- family building benefits
- life and disability insurance
- paid vacation
- paid holidays
- other paid leaves of absence
- tuition reimbursement
- support for caregiving needs
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