Technicien de production, Fractionnement - Manufacturing Technician, Fractionation

Grifols; Montreal; On-site; CAD 64,000 - 90,000; Full time

Job summary

Une entreprise mondiale de soins de santé cherche un Technicien de Fabrication à Montréal. Le candidat doit avoir une expérience en biopharmacie, des compétences en gestion des priorités et être bilingue (français et anglais). Les responsabilités incluent l'opération d'équipements de fabrication et l'exécution de documents de qualité pour garantir la conformité aux normes cGMP.

Qualifications

• 1 an d'expérience dans l'industrie biopharmaceutique ou pharmaceutique.
• Bilinguisme en français et anglais requis.
• Capacité à soulever au moins 15 kg.

Responsibilities

• Configuration et nettoyage de l'équipement de fabrication.
• Exécution des dossiers de lot de fabrication.
• Inspection des produits emballés pour détecter d'éventuels défauts.

Skills

Capacité à travailler dans un environnement dynamique

Gestion de plusieurs priorités

Travail d'équipe

Autonomie

Education

Diplôme d'études secondaires

Diplôme en Technologie Pharmaceutique ou diplôme universitaire en Ingénierie ou Science

Job description

Overview

Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position

Technician title bilingual presentation: Manufacturing Technician - Fractionation

Title: Manufacturing Technician

Reports to: Supervisor or Manager

Purpose Statement

The Manufacturing Technician will be primarily assigned to one of the following areas: Fractionation but will be expected to develop multi-disciplinary skills by alternating to other areas of manufacturing (Albumin Purification, IGIV Purification, Filling, Packaging) 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.

Le technicien de fabrication sera principalement affecté à l'un des domaines suivants : fractionnement, mais devra acquérir des compétences multidisciplinaires en alternant avec d'autres domaines de la fabrication (purification albumine, purification IgIV, remplissage, conditionnement) afin de répondre aux besoins de l'entreprise. Le technicien de fabrication travaille dans un environnement de fabrication réglementé par les BPF, les SOP, les procédures de sécurité et toutes les politiques/règlements de l'entreprise.

Key Duties and Responsibilities

• Set up, operation and cleaning the following equipment (depending on the designated manufacturing area): buffer preparation skids, centrifuge, fractionation skids and filter presses, TFF skids and columns, chromatography skids, filtration skids and filling line (within an isolator), automatic packaging line;
• Set up and operation: CIP/ SIP skids, autoclaves and parts washers;
• Set-up, operate and troubleshoot various packaging equipment including:
• Set-up and operate multiple label verification vision systems on vial labelers and cartoners.
• Set-up and operate multiple vial labelers, vial cartoners, shrink-banding machines and other equipment related to final container labeling.
• Conduct periodic challenges for the various packaging systems.
• Inspect packaged and pre-packaged products for possible defects (manual and semi-automatic visual inspection);
• Conduct an accurate count of pre and post packaged products;
• Execution of all manufacturing batch records in the designated areas based on the training completed within that area;
• Escalation of all of issues potentially impacting cGMP of the respective Manufacturing area and or manufacturing process to the responsible manager immediately;
• Participate in all manufacturing activities related to the assigned area including sampling (process and cleaning validation, environmental monitoring, clean utilities), in-process testing, weighing, calibration and maintenance of equipment (pH meter...);
• Actively participate in writing and implementing GMP documents (SOPs, batch records) using the change control system and maintain records of all necessary information/data as per GDPs;
• Execute daily, weekly and monthly cleaning in the respective manufacturing area following the applicable standard operating procedures;
• Ensure all manufacturing supplies within the respective manufacturing area are maintained and replenished as required;

Qualifications

• High school diploma. CEGEP/College diploma in Pharmaceutical Technology or university degree in Engineering or Science preferred.
• Preferred 1-year experience within the biopharmaceutical, pharmaceutical, healthcare industry.
• Ability to work in a fast-paced environment and manage multiple priorities
• Ability to work independently as well as in a team environment
• Must be able to lift, push, pull at least 15kg and wear PPE as required
• Some tasks will involve working in a refrigerated environment
• Experience in clean room operation preferred.
• Bilingualism (French and English) both spoken and written. L’exigence de l’anglais est requise pour la documentation, les rapports et les interactions avec Santé Canada, FDA, et autres départements multi-disciplinaires dans l’entreprise mais basés hors-Québec et hors-Canada (Espagne, USA).
• For manufacturing technicians performing visual inspection as a qualified person, the following additional qualifications are required:
• Eye sight exam including color blindness testing

Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec

Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec

Location: Montreal

Location details may vary by posting. Please refer to the job posting or internal notices for final location.

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