Manufacturing Technician

1 week ago

Canada G Canada Therapeutics Full time

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**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
- 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.
- Minimum 1-year experience within the biopharmaceutical, pharmaceutical, healthcare industry is preferred.
- 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 at least 15kg and wear PPE as required
- Some tasks will involve working in a refrigerated environment
- Experience in clean room operation is an asset
- Bilingualism (French and English) both spoken and written

**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 p

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