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GRIFOLS, S.A.

Superviseur, Purification IGIV Supervisor

Montreal, QC, Canada

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Job details

Posting language: English · French
Posted: Nov 9, 2026

Original job description

English section of this bilingual listing.

The Supervisor, IGIV Purification, is responsible for the daily manufacturing shift activities occurring in the IGIV Purification area of Production within the Grifols Canada Therapeutics (GCT) manufacturing facility. They will be responsible for ensuring department quality, safety, delivery and productivity objectives are met. The Supervisor, IGIV Purification is highly knowledgeable in cGMPs and protein purification manufacturing processes. This role supervises all team members assigned to them. The role is responsible for investigating and completing Quality notifications, drafting and reviewing SOPs and batch production records.

Key Duties and Responsibilities

Leading and directing the daily manufacturing shift activities ensure all tasks are assigned and follows up throughout the shift on progress.
Ensure notifications (quality or preventative maintenance) are issued in a timely manner and completes investigation in a timely manner
Responsible for ensuring all manufacturing schedules, products and materials are delivered
Trains IGIV Purification manufacturing personnel on process activities, including safety requirements and cGMP requirements. Identify technical and non-technical development gaps and implement applicable plans and targets. Reviews safety cases and identifies or implements corrective actions.
Develops, trains, and monitors IGIV Purification 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, in addition to all federal health authority regulations related to IGIV Purification 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, standard operating procedures, etc.) to close on time
Make sure all equipment is working properly. Requests for equipment and facility repairs, or modifications
Resolves operational and equipment issues and makes recommendations. Also coordinates emergency repairs, changes, and preventative maintenance activities with the utility team.
Coordinates manufacturing activities with other departments. This includes working closely with quality control, materials management, quality assurance, validation, etc.

Qualifications:

CEGEP or technical degree mandatory. BS degree in Degree in Science, Engineering or related field preferred. Previous experience in biologics protein IGIV Purification manufacturing is an asset.
1 to 3 years 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.
Good 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 a knowledge base and proficiency in Microsoft Word, Excel, Power Point, and Project.

Read the full bilingual original

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.

Titre du poste : Superviseur, Purification IgIV (Gamunex®)

Relève de : Directeur de la fabrication

Le Superviseur, Purification IgIV est responsable des quarts de travail quotidiens qui se déroulent dans la zone de production de Purification IgIV au sein 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 Purification IgIV connaît très bien les BPF et les procédés de purification 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.

Principales tâches et responsabilités

Diriger et diriger les activités quotidiennes du quart de travail de fabrication s'assure que toutes les tâches sont assignées et fait le suivi tout au long du quart de travail.

S'assurer que les avis (de qualité ou entretien préventif) sont émis en temps opportun et que l'enquête est terminée en temps opportun

Responsable de s'assurer que tous les calendriers de fabrication, les produits et les matériaux sont livrés

Forme le personnel de Purification IgIV sur les activités de procédé, y compris les exigences de sécurité et les exigences en matière de BPF. Cerner les lacunes techniques et non techniques en matière de développement et mettre en œuvre les plans et les cibles applicables. Examiner les cas de sécurité et déterminer ou mettre en œuvre des mesures correctives.

Développer, former et surveiller le personnel de Purification IgIV pour s'assurer que les produits sont fabriqués conformément aux exigences réglementaires définies, aux procédures de GCT et aux règlements GxP.

Assurer la conformité aux procédures et aux politiques d'exploitation du site, y compris les protocoles de santé et de sécurité, ainsi qu'à tous les règlements des autorités sanitaires fédérales liés aux opérations de Purification IgIV.

Comprend et adhère aux bonnes pratiques de documentation (BPD)

Coordonner et rédiger les examens des documents liés aux lots, y compris les dossiers de lots et les PON

Exécuter les affectations du système de gestion de la qualité (CAPA, contrôle des changements, procédures opérationnelles normalisées, etc.) pour les clôturer à temps

Assurez-vous que tout l'équipement fonctionne correctement. Demandes de réparation ou de modification de l'équipement et des installations

Résoudre les problèmes opérationnels et d'équipement et faire des recommandations. Coordonne également les réparations d'urgence, les changements et les activités d'entretien préventif avec l'équipe des services publics.

Coordonner les activités de fabrication avec les autres services. Cela comprend la collaboration étroite avec le contrôle de la qualité, la gestion des matériaux, l'assurance de la qualité, la validation, etc.

Qualifications requises

Diplôme collégial ou technique obligatoire. Baccalauréat en sciences, en génie ou dans un domaine connexe de préférence. Expérience antérieure dans la fabrication de protéines biologiques et de purification IgIV est un atout.

1 à 3 ans d'expérience en leadership/superviseur de fabrication dans un environnement biopharmaceutique cGMP.

Bonne compréhension des principes de fonctionnement de la plupart des équipements de traitement. Solide connaissance des principes techniques et scientifiques associés aux processus aseptiques.

Bonne connaissance des systèmes de contrôle automatisés.

Bonne connaissance des exigences et des règlements des installations cGMP, de l'OSHA, de l'EPA et de la FDA.

Bonne connaissance des opérations aseptiques, des statistiques, de la conception d'équipements, du contrôle des procédés, de la mise à l'échelle des procédés, des procédés pharmaceutiques aseptiques et de la validation des équipements.

Capacité de dépanner et d'entretenir les systèmes, l'équipement et les processus de fabrication.

Capacité à s'habiller de manière aseptique pour les opérations en salle blanche.

Capacité à réagir rapidement pour comprendre et résoudre les problèmes.

Excellentes compétences en communication et en documentation, en organisation et en dépannage

Capacité à lire, comprendre et suivre avec précision les SOP et les lignes directrices de l'entreprise

Doit posséder de bonnes à excellentes compétences en écriture et en informatique avec une base de connaissances et une maîtrise de Microsoft Word, Excel, Power Point et Project.

Bilinguisme (français et anglais) parlé et écrit (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).

Position title: Supervisor, IGIV Purification (Gamunex®)

Reports to: Director Manufacturing

Key Duties and Responsibilities

Leading and directing the daily manufacturing shift activities ensure all tasks are assigned and follows up throughout the shift on progress.

Ensure notifications (quality or preventative maintenance) are issued in a timely manner and completes investigation in a timely manner

Responsible for ensuring all manufacturing schedules, products and materials are delivered

Trains IGIV Purification manufacturing personnel on process activities, including safety requirements and cGMP requirements. Identify technical and non-technical development gaps and implement applicable plans and targets. Reviews safety cases and identifies or implements corrective actions.

Develops, trains, and monitors IGIV Purification 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, in addition to all federal health authority regulations related to IGIV Purification 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, standard operating procedures, etc.) to close on time

Make sure all equipment is working properly. Requests for equipment and facility repairs, or modifications

Resolves operational and equipment issues and makes recommendations. Also coordinates emergency repairs, changes, and preventative maintenance activities with the utility team.

Coordinates manufacturing activities with other departments. This includes working closely with quality control, materials management, quality assurance, validation, etc.

Qualifications:

CEGEP or technical degree mandatory. BS degree in Degree in Science, Engineering or related field preferred. Previous experience in biologics protein IGIV Purification manufacturing is an asset.

1 to 3 years 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.

Good 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 a knowledge base and proficiency in Microsoft Word, Excel, Power Point, and Project.

Bilingualism (French and English) both spoken and written (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).

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

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More about this job

Responsibilities

The Supervisor is responsible for leading daily manufacturing shift activities in the IGIV Purification area to ensure quality, safety, and productivity objectives are met. They oversee team members, manage quality notifications, and ensure compliance with cGMP regulations and standard operating procedures.

Requirements

Candidates must have a technical degree or college diploma, with a bachelor's degree in science or engineering preferred. The role requires 1 to 3 years of manufacturing leadership experience in a cGMP biopharmaceutical environment and proficiency in both English and French.

Skills

Protein purification
cGMP
Aseptic processing
Manufacturing leadership
Quality management systems
CAPA
SOP development
Batch record review
Automated control systems
Troubleshooting
Equipment validation
Process scale-up
Documentation
Team supervision
Regulatory compliance
Microsoft Office

Visa sponsorship

Not detected in the job text

Keywords

IGIV Purification
Biologics
cGMP
Aseptic processing
Manufacturing
Quality assurance
CAPA
SOP
Batch records
FDA
OSHA
EPA
Protein purification
Cleanroom
Validation
Process control
Automated control systems
Biopharmaceutical
Leadership
Regulatory compliance
GDP
Preventative maintenance
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Project
Bilingual
Gamunex

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