Manufacturing Technician

7 months ago

Montréal, Canada G Canada Therapeutics Full time

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

**Énoncé du poste**

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 aider à 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
- Configurez, utilisez et dépannez divers équipements d’emballage, notamment:

- Mettre en place et exploiter plusieurs systèmes de vision de vérification des étiquettes sur les étiqueteuses et les cartonneurs de flacons.
- Installer et u

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