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Manufacturing Technician
3 months ago
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
**Énoncé de l'objet**
- Le technicien de la fabrication sera principalement affecté à l'un des domaines suivants: Fractionation, purification, Fill / Finish ou emballage, mais on s'attendra à ce qu'il développe des compétences multidisciplinaires en alternant avec d'autres domaines de la fabrication pour répondre aux demandes de l'entreprise. Le technicien de fabrication travaille dans un environnement de fabrication réglementé par les CGMPs, les SOP, les procédures de sécurité et toutes les politiques / réglementations de l'entreprise.
- Principales tâches et responsabilités
- Installer, faire fonctionner et nettoyer l'équipement suivant (selon la zone de fabrication désignée) : Patins de préparation de tampon, centrifugeuse, patins de fractionnement et filtre-presses, patins et colonnes de FFT, patins et colonnes de chromatographie, patins de chromatographie, patins de filtration et ligne de remplissage (à l'intérieur d'un isolateur)
- Mise en place et exploitation: CIP / SIP Patins, autoclaves et laveuses de pièces
- Exécution de tous les registres de lots de fabrication dans les zones désignées en fonction de la formation complétée dans cette zone
- L'escalade de tous les problèmes susceptibles d'avoir une incidence sur les BPF de la zone de fabrication et/ou du processus de fabrication respectifs au gestionnaire responsable immédiatement
- Participer à toutes les activités de fabrication liées à la zone assignée, y compris l'échantillonnage (validation du processus et du nettoyage, surveillance environnementale, services publics propres), les essais en cours de fabrication, la pesée, l'étalonnage et l'entretien de l'équipement (pH-mètre...)
- Participer activement à la rédaction et à la mise en œuvre des documents sur les BPF (PON, registres de lots) à l'aide du système de contrôle des changements et tenir des registres de tous les renseignements et données nécessaires conformément aux PGB
- Effectuer un nettoyage quotidien, hebdomadaire et mensuel dans la zone de fabrication respective en suivant les procédures d'exploitation normalisées applicables
- S'assurer que toutes les fournitures de fabrication dans la zone de fabrication respective sont entretenues et réapprovisionnées au besoin
**Qualifications requises**:
- Diplôme d'études secondaires. Diplôme d'études collégiales ou collégiales en technologie pharmaceutique ou diplôme universitaire en génie ou en sciences de préférence.
- Une expérience mínimale de 1 an dans l'industrie biopharmaceutique, pharmaceutique et des soins de santé est préférable.
- Capacité de travailler dans un environnement au rythme rapide et de gérer de multiples priorités
- Capacité de travailler de manière indépendante ainsi que dans un environnement d'équipe
- Doit être capable de soulever au moins 15 kg et de porter de l'EPI au besoin
- Certaines tâches impliqueront de travailler dans un environnement réfrigéré
- Une expérience dans l'exploitation des salles propres est un atout
- Bilinguisme (français et anglais) à la fois parlé et écrit
**Position Title**: Manufacturing Technician **Reports to**: Manufacturing Manager
**Purpose Statement**
The Manufacturing technician will be primarily assigned to one of the following areas: Fractionation, Purification, Fill/Finish or Packaging but will be expected to develop multi-disciplinary skills by alternating to other areas of Manufacturing to assist with business demands. The Manufacturing technician is working in a manufacturing environment regulated by cGMPs, SOPs, safety procedures and all company policies/regulations.
**Key Duties and Responsibilities**
- Set up, operation and cleaning the following equipment (depending on the designated Manufacturing area): Buffer Preparation Skids, Centrifuge, Fractionat
