Superviseur de fractionnement / Fractionation Supervisor

GRIFOLS, S.A.•Montreal, QC

11d•Onsite

About The Position

The Supervisor, Fractionation, is responsible for the daily manufacturing shift activities occurring in the Fractionation 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, Fractionation is highly knowledgeable in cGMPs and protein Fractionation 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.

Requirements

CEGEP or technical degree mandatory. BS degree in Science, Engineering or related field preferred.
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).

Nice To Haves

Previous experience in biologics protein fractionation manufacturing is an asset.

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 Fractionation 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 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, in addition to 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, 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.