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Production Specialist

1 month ago

Charlottetown, Prince Edward Island, Canada Merck Full time

Recherchez un spécialiste en fabrication biologique pour produire des produits vétérinaires conformément aux normes de fabrication GMP et aux directives de sécurité.

Les principales responsabilités incluent :

  • Conformité aux exigences de sécurité, aux BPF, aux SOP et à la documentation de fabrication.
  • Production de produits biologiques vétérinaires conformément à leur plan de produit/dossiers de produit approuvés et aux directives BPF.
  • Récupération et purification de produits biologiques en utilisant une unité TFF à l'échelle du processus, des colonnes et un système de chromatographie.
  • Utilisation et entretien des instruments et équipements de production, tels que les pH-mètres, les conductimètres, le spectrophotomètre, l'équipement TFF, les pompes péristaltiques, les pompes rotatives, les systèmes de chromatographie.
  • Conditionnement des colonnes à l'aide de patins de conditionnement, analyse du processus à l'aide d'un spectrophotomètre, tests d'intégrité sur divers types de filtres.
  • Rédaction et révision des dossiers de lots, SOP, documents de qualification pour les opérations en aval.
  • Utilisation du système SAP pour la consommation de matériaux en production.
  • Collaboration avec d'autres services impliqués dans la fabrication GMP pour planifier la production, les tests et la commercialisation des produits.
  • Travail en étroite collaboration sur un projet de transfert de technologie, du développement du processus à la fabrication.
  • Travail avec le groupe de fabrication en amont pour fournir des ressources.
  • Effectuer des tâches sous une supervision minimale et dans des délais serrés pour respecter les calendriers de production.
  • Résoudre les problèmes liés aux opérations de TFF et de chromatographie.
  • Aider à l'entretien de l'équipement de production en bon état conformément aux spécifications du fabricant.
  • Maintenir la propreté des zones de production et aider aux procédures de désinfection, nettoyer et stériliser les articles utilisés dans les purifications.
  • Enquêter efficacement sur les événements qui se produisent lors de toute défaillance de lot.
  • Faire preuve de leadership envers ses pairs sur le terrain en démontrant ses connaissances, son expertise et en mettant en œuvre des améliorations de processus.

Les qualifications requises incluent :

  • Éducation de 12e année, un diplôme d'études collégiales de 2 ans est préférable.
  • 3 années d'expérience dans l'industrie de fabrication biologique GMP.
  • 3 années d'expérience dans la purification de produits biologiques en utilisant des procédés de filtration TFF et de chromatographie à grande échelle.
  • Expérience dans la réalisation d'enquêtes et la rédaction d'écarts.
  • Compétences informatiques intermédiaires/expertes utilisant MS Office (Word, Excel, Power Point), une expérience SAP est requise.
  • Excellentes compétences interpersonnelles, tant en communication qu'à l'écrit.
  • Compréhension technique approfondie des systèmes qualité et des exigences réglementaires.

Les autres informations importantes incluent :

  • Capacité de travailler par quarts (quarts de jour de 12 heures, 3 à 4 jours par semaine, y compris certains week-ends).
  • Flexibilité/capacité de faire des heures supplémentaires si l'entreprise l'exige.
  • Aide aux procédures de désinfection impliquant des produits chimiques dangereux.
  • Capacité de soulever, de déplacer et de manœuvrer de l'équipement de petite à moyenne taille.
  • Capacité de travailler sur de longues périodes.
  • Capacité de monter fréquemment des échelles ou des escaliers.
  • Capacité de lire, d'écrire, de comprendre et de se conformer aux procédures opérationnelles standard appropriées.

Merck & Co., Inc. est une entreprise leader dans la fabrication de produits biologiques vétérinaires. Nous sommes fiers de notre équipe diversifiée et engagée qui travaille ensemble pour atteindre nos objectifs.