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Job Title

Supervisor, Fractionation

Reports to

Fractionation Manager

Location

Montreal, Quebec, Canada

Job Overview

Le Superviseur, Fractionement est responsable des quarts de travail quotidiens qui se déroulent dans la zone de fractionnement de la production de l'installation de fabrication de Grifols Canada Thérapeutiques (GCT). Il sera chargé de veiller à ce que les objectifs de qualité, de sécurité, de prestation et de productivité du service soient atteints. Le Superviseur, Fractionation, connaît très bien les GMPc et les procédés de fabrication du fractionnement des protéines. Ce rôle supervise tous les membres de l'équipe qui leur sont assignés. Le rôle est responsable d'enquêter et de remplir les avis de qualité, de rédiger et d'examiner les PON et les dossiers de production par lots.

Key Duties and Responsibilities

- Leading and directing the daily manufacturing shift activities, ensuring all tasks are assigned and followed up throughout the shift.
- Ensuring notifications (quality or preventative maintenance) are issued in a timely manner and investigations are completed promptly.




- Responsible for ensuring all manufacturing schedules, products and materials are delivered.
- Trains Fractionation manufacturing personnel on process activities, including safety requirements and cGMP requirements; identifies technical and non‑technical development gaps and implements applicable plans and targets; reviews safety cases and implements corrective actions.
- Develops, trains, and monitors Fractionation personnel to ensure products are manufactured in accordance with defined regulatory requirements, GCT’s procedures, and GxP regulations.
- Ensures compliance with site operating procedures and policies, including health and safety protocols, and all federal health authority regulations related to Fractionation manufacturing operations.
- Understands and adheres to Good Documentation Practices (GDP).
- Coordinates and drafts reviews of batch‑related documents, including batch records and SOPs.
- Executes quality management system assignments (CAPA, change control, SOPs, etc.) to close on time.
- Ensures all equipment is working properly; requests repairs or modifications for equipment and facility.
- Resolves operational and equipment issues, makes recommendations, and coordinates emergency repairs, changes, and preventative maintenance with the utility team.
- Coordinates manufacturing activities with other departments,



collaborating closely with quality control, materials management, quality assurance, validation, and others.

Qualifications

- CEGEP or technical degree mandatory; BS degree in Science, Engineering or related field preferred. Previous experience in biologics protein fractionation manufacturing is an asset.
- 1 to 3 years of manufacturing leadership/supervisor experience in a cGMP biopharmaceutical environment.
- Good understanding of the operating principles of most process equipment; strong knowledge of technical and scientific principles associated with aseptic processing.
- Good knowledge of automated control systems.
- Positive knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations.
- Good knowledge of aseptic operations, statistics, equipment design, process control, process scale‑up, aseptic pharmaceutical processes, and equipment validations.
- Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
- Ability to dress aseptically for cleanroom operations.
- Ability to react quickly to understand and solve problems.
- Excellent communication and documentation skills, organizational and troubleshooting skills.
- Ability to accurately read, understand, and follow company SOPs and guidelines.
- Must possess good to excellent writing and computer skills with proficiency in Microsoft Word, Excel, Power Point, and Project.
- Bilingualism (French and English) spoken and written; English proficiency required for documentation and communication with sites outside Quebec and Canada (Spain, USA).

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📌 Superviseur de Production - Fractionnement / Manufacturing Supervisor - Fractionation (Montreal)
🏢 Grifols
📍 Montreal