Job Description

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.

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, Fractionation Skids and Filter presses, TFF Skids and columns, Chromatography Skids, Filtration Skids and Filling line (within an isolator)
• 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;
• 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
• For manufacturing technicians performing visual inspection as a qualified person, the following additional qualifications are required:

• Eye sight exam including color blindness testing

\xc3\x89nonc\xc3\xa9 du poste

Le technicien de la fabrication sera principalement affect\xc3\xa9 \xc3\xa0 l\'un des domaines suivants: Fractionation, Purification, Fill / Finish ou emballage, mais on s\'attendra \xc3\xa0 ce qu\'il d\xc3\xa9veloppe des comp\xc3\xa9tences multidisciplinaires en alternant avec d\'autres domaines de la fabrication pour aider \xc3\xa0 r\xc3\xa9pondre aux demandes de l\'entreprise. Le technicien de fabrication travaille dans un environnement de fabrication r\xc3\xa9glement\xc3\xa9 par les CGMPs, les SOP, les proc\xc3\xa9dures de s\xc3\xa9curit\xc3\xa9 et toutes les politiques / r\xc3\xa9glementations de l\'entreprise..

Principales t\xc3\xa2ches et responsabilit\xc3\xa9s

• Installer, faire fonctionner et nettoyer l\'\xc3\xa9quipement suivant (selon la zone de fabrication d\xc3\xa9sign\xc3\xa9e ) : Patins de pr\xc3\xa9paration 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 (\xc3\xa0 l\'int\xc3\xa9rieur d\'un isolateur)
• Mise en place et exploitation: CIP / SIP Patins, autoclaves et laveuses de pi\xc3\xa8ces
• Configurez, utilisez et d\xc3\xa9pannez divers \xc3\xa9quipements d\'emballage , notamment :

• Mettre en place et exploiter plusieurs syst\xc3\xa8mes de vision de v\xc3\xa9rification des \xc3\xa9tiquettes sur les \xc3\xa9tiqueteuses et les cartonneurs de flacons.
• Installer et utiliser plusieurs \xc3\xa9tiqueteuses de flacons, cartonneurs de flacons, machines \xc3\xa0 bandes r\xc3\xa9tractables et autres \xc3\xa9quipements li\xc3\xa9s \xc3\xa0 l\'\xc3\xa9tiquetage final des conteneurs.
• Mener des d\xc3\xa9fis p\xc3\xa9riodiques pour les diff\xc3\xa9rents syst\xc3\xa8mes d\'emballage
• Inspecter les produits emball\xc3\xa9s et pr\xc3\xa9emball\xc3\xa9s pour d\xc3\xa9tecter d\'\xc3\xa9ventuels d\xc3\xa9fauts;
• Effectuer un d\xc3\xa9nombrement pr\xc3\xa9cis des produits emball\xc3\xa9s avant et apr\xc3\xa8s l\'emballage;
• Ex\xc3\xa9cution de tous les registres de lots de fabrication dans les zones d\xc3\xa9sign\xc3\xa9es en fonction de la formation compl\xc3\xa9t\xc3\xa9e dans cette zone
• L\'escalade de tous les probl\xc3\xa8mes susceptibles d\'avoir une incidence sur les BPF de la zone de fabrication et/ou du processus de fabrication respectifs au gestionnaire responsable imm\xc3\xa9diatement
• Participer \xc3\xa0 toutes les activit\xc3\xa9s de fabrication li\xc3\xa9es \xc3\xa0 la zone assign\xc3\xa9e, y compris l\'\xc3\xa9chantillonnage (validation du processus et du nettoyage, surveillance environnementale, services publics propres), les essais en cours de fabrication, la pes\xc3\xa9e, l\'\xc3\xa9talonnage et l\'entretien de l\'\xc3\xa9quipement (pH-m\xc3\xa8tre...)
• Participer activement \xc3\xa0 la r\xc3\xa9daction et \xc3\xa0 la mise en \xc5\x93uvre des documents sur les BPF (PON, registres de lots) \xc3\xa0 l\'aide du syst\xc3\xa8me de contr\xc3\xb4le des changements et tenir des registres de tous les renseignements et donn\xc3\xa9es n\xc3\xa9cessaires conform\xc3\xa9ment aux PGB
• Effectuer un nettoyage quotidien, hebdomadaire et mensuel dans la zone de fabrication respective en suivant les proc\xc3\xa9dures d\'exploitation normalis\xc3\xa9es applicables

S\'assurer que toutes les fournitures de fabrication dans la zone de fabrication respective sont entretenues et r\xc3\xa9approvisionn\xc3\xa9es au besoin

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

Grifols