Engineer VI – QC Applications

Emploi pas sur LinkedIn

🕒 il y a 2 mois

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $90 000 - $153 750 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👷🏻‍♀️ Ingénieur

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Resilience

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 2020

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

Biotechnology • Pharmaceuticals • Science

Resilience est une entreprise innovante de premier plan dans le domaine de la bioproduction, axée sur le développement de nouveaux médicaments. Spécialisée dans la fabrication de médicaments complexes tels que les thérapies cellulaires et géniques, Resilience s'associe à des entreprises de biotechnologie de petite et moyenne taille pour fournir des solutions sur mesure qui exploitent des technologies de pointe et des avancées scientifiques. Leur approche comprend des capacités de fabrication de substances médicamenteuses et de produits finis de haute technologie, de bout en bout, visant à garantir une production rapide, sûre et évolutive. Resilience opère principalement en Amérique du Nord, avec une expertise dans la fourniture de solutions conformes à la réglementation sur les marchés mondiaux, améliorant la fiabilité et l'accessibilité des chaînes d'approvisionnement biopharmaceutiques.

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

🎯 Exigences

• 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.

🏖️ Avantages

• 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