Engineer VI – QC Applications

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🕒 Abril 4

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $90.000 - $153.750 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷🏻‍♀️ Engenheiro

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Resilience

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2020

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

Biotechnology • Pharmaceuticals • Science

A Resilience é uma empresa líder em inovação na bioprodução, focada no desenvolvimento de novos medicamentos. Especializando-se na fabricação de medicamentos complexos, como terapias celulares e gênicas, a Resilience faz parcerias com empresas de biotecnologia de pequeno e médio porte para fornecer soluções personalizadas que aproveitam tecnologias de ponta e avanços científicos. Sua abordagem inclui capacidades de fabricação de substâncias e produtos farmacêuticos de ponta a ponta, de alta tecnologia, visando garantir uma produção rápida, segura e escalável. A Resilience opera principalmente na América do Norte, com expertise em fornecer soluções em conformidade regulatória para mercados globais, aprimorando a confiabilidade e acessibilidade das cadeias de suprimentos biofarmacêuticas.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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