GxP IT Systems Engineer, Manufacturing and LabsModerna Therapeutics • Laval, QC, CA
GxP IT Systems Engineer, Manufacturing and Labs
Moderna Therapeutics • Laval, QC, CA
30+ days ago
Job type
- Full-time
Job descriptionAssurer le soutien des systèmes GMP, incluant les inspections, déviations, CAPA et examens périodiques ; garantir la conformité aux SOP, aux formations réglementaires, à l’intégrité des données et aux réglementations applicables. Servir de point de contact de premier niveau pour le soutien aux systèmes de fabrication, en partenariat étroit avec les équipes d’ingénierie et d’exploitation afin de maintenir la disponibilité des systèmes. Surveiller, trier et résoudre les billets liés aux systèmes de plancher de production (stations de travail, imprimantes d’étiquettes, IHM, Thin Manager, scanneurs, périphériques), en respectant les SLA et en communiquant de manière transparente. Dépanner l’infrastructure (serveurs Windows, VMware / Hyper-V, AD, DNS / DHCP, services d’impression / fichiers, synchronisation de temps) et assurer l’escalade si nécessaire. Exécuter les changements, correctifs et activités de maintenance GxP approuvés dans le cadre du contrôle formel des changements, en documentant rigoureusement les preuves et en maintenant l’état validé. Effectuer la surveillance et les vérifications de l’état des systèmes à l’aide de Dynatrace, Splunk, PagerDuty ; traiter de manière proactive les problèmes de performance, de stabilité ou de capacité. Déployer les outils de cybersécurité (CrowdStrike), corriger les alertes, appliquer les correctifs de vulnérabilité et gérer les certificats en conformité avec les politiques de sécurité. Maintenir les inventaires, les configurations de référence, la documentation des topologies et assurer l’exactitude du CMDB. Mettre en œuvre, maintenir et administrer les appareils informatiques des utilisateurs finaux (ordinateurs portables, téléphones mobiles, etc.), y compris le système d’exploitation, la suite MS Office, les applications tierces et la résolution des problèmes matériels. Dépanner, réparer et configurer les appareils iOS d’Apple, les ordinateurs portables, l’imagerie, l’effacement des données et le contrôle des actifs tout en maintenant une documentation détaillée des billets. Offrir une expérience de service exemplaire aux utilisateurs finaux. Collaborer avec les équipes d’automatisation, d’ingénierie de l’usine / laboratoire, de CQ / AQ et du noyau numérique afin de restaurer les services rapidement, de coordonner les fenêtres de maintenance et de communiquer les pannes ainsi que les résumés des causes racines. Participer aux comités de changements / revues consultatives avec un accent sur l’état de préparation opérationnelle, la gestion des risques et le maintien de l’état validé. Baccalauréat en informatique, technologies de l’information, génie industriel, sciences physiques ou dans un domaine connexe, ou expérience pertinente. Minimum de 5 à 6 ans d’expérience en soutien des systèmes TI / OT en fabrication et en laboratoires. Expérience en environnement biopharmaceutique et GxP. Expérience avec les environnements virtuels (VMware / Hyper-V) et / ou plateformes infonuagiques (AWS de préférence). Expérience avec les bases de données relationnelles (SQL Server ou Oracle). Expérience avec serveurs d’applications et web (IIS). Expérience avec systèmes de sauvegarde / récupération (Acronis, Veeam, N2WS, etc.). Expérience avec logiciels de protection des terminaux (CrowdStrike, Symantec, McAfee, Carbon Black, etc.). Expérience avec outils d’infrastructure (Dynatrace, PagerDuty, Splunk). Excellentes compétences de dépannage Windows et Microsoft Office Suite, ainsi que de dépannage matériel. Expérience de soutien aux appareils Apple (MacOS et iOS), incluant l’environnement JAMF. Expérience avec ServiceNow un atout. Compréhension des concepts de routage réseau, de commutation et de pare-feu. Dans le cadre de l’engagement de Moderna à bâtir une main-d’œuvre durable, un minimum de 2 ans d’autorisation de travail est requis pour ce rôle. Créatif(ve), analytique, avec de solides aptitudes à résoudre des problèmes. Attitude « peu importe ce qu’il faut ». Capacité de dépanner des problèmes complexes dans un environnement sous pression. Capacité d’agir comme intermédiaire entre les équipes TI, Automatisation, Ingénierie, Fabrication, CQ et AQ. Capacité de travailler de façon autonome, avec une supervision limitée, pour atteindre les résultats attendus. Capacité de réagir sous pression à toute situation, de manière professionnelle et avec des résultats positifs, dans un environnement multi-sites, 24 / 7. Capacité de travailler fort pour mettre en œuvre des changements dans un environnement dynamique et exigeant, tout en maintenant une approche positive avec la direction et les collègues. Style de travail hautement collaboratif. Solides compétences interpersonnelles avec la capacité d’établir des relations professionnelles fructueuses. Capacité de travailler efficacement dans un environnement interfonctionnel et rapide. Implement, maintain, and administer end-user computing devices (laptops, mobile phones, etc.) including OS, MS Office Suite, third-party applications, and hardware issues. Troubleshoot, repair, and configure Apple iOS devices, laptops, imaging, data wiping, and asset control while maintaining detailed ticket documentation. Deliver best-in-class customer experience when working with end users. Partner with Automation, Plant / Lab Engineering, QC / QA, and Digital Core teams to restore service rapidly, schedule maintenance windows, and communicate outages and root cause summaries. Participate in change / advisory boards with a focus on operational readiness, risk management, and validated state impacts. We obsess over learning. We don’t have to be the smartest we have to learn the fastest. In this role, you’ll need to absorb complex manufacturing systems quickly and adapt to evolving tools, ensuring you remain at the cutting edge of IT / OT integration. We digitize everywhere possible using the power of code to maximize our impact on patients. As a GxP IT Systems Engineer, your focus on leveraging digital tools, observability platforms, and automation will be critical to streamlining operations and ensuring regulatory compliance. Bachelor's degree in computer science, Information Technology, Industrial Engineering, physical science or related field or relevant experience. Minimum of 5-6 years of experience supporting IT / OT systems in manufacturing and labs. Experience working in a BioPharma, GxP environment Experience working with virtual environment (VMware / Hyper-V) and / or cloud platform (AWS preferred) Experience working with RDBMS (SQL Server or Oracle) Experience working with application and web server (IIS). Experience working with backup / recovery systems (Acronis, Veeam, N2WS, etc.) Experience working with Cybersecurity endpoint protection applications (CrowdStrike, Symantec, McAfee, Carbon Black, etc.) Experience working with infrastructure tools (Dynatrace, Pager Duty, Splunk) Excellent Windows and Microsoft Office Suite trouble shooting skills, as well as hardware trouble shooting skills. Experience with Apple device support for both MacOS and iOS, including the JAMF environment Experience with Service Now a plus Understanding of network routing, switching and firewall concepts. As part of Moderna’s commitment to build a sustainable workforce, a minimum of 2 years of work authorization is required for this role. Creative, analytical, and strong problem-solving skills. ‘Whatever it takes’ attitude. Ability to troubleshoot complex issues in a high pressure environment. Ability to liaison between IT, Automation, Engineering, Manufacturing, QC, and QA teams. Ability to work independently, with limited direction, to achieve expected results. Ability to react under pressure to any given situation that may arise, in a professional manner and with positive results, in support of a multi-location, 24x7 environment. Ability to work hard to effect change in a dynamic, high standards environment while
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Manufacturing Engineer • Laval, QC, CA
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