Engineer VI – QC Applications

Job not on LinkedIn

🕒 April 4

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $90k - $153.8k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

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Resilience

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Resilience is a leading biomanufacturing innovation company focused on the development of novel medicines. Specializing in the manufacturing of complex medicines such as cell and gene therapies, Resilience partners with small and mid-sized biotech firms to provide customized solutions that leverage cutting-edge technologies and scientific advancement. Their approach includes high-tech, end-to-end drug substance and drug product manufacturing capabilities aimed at ensuring rapid, safe, and scalable production. Resilience operates primarily in North America, with expertise in delivering regulatory-compliant solutions across global markets, enhancing the reliability and accessibility of biopharmaceutical supply chains.

📋 Description

• 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