IGIV Purification Supervisor

Grifols

. Lead and direct daily manufacturing shift activities, assign tasks, and follow up on progress .

Posted 11/9/2026full-timeMontreal • CanadaJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in manufacturing leadership within a cGMP biopharmaceutical environment, ensuring compliance with regulatory requirements and quality management systems. Proficient in aseptic processing, equipment validation, and effective communication in both English and French.

Highest-signal resume keywords

Manufacturing LeadershipCGMP ComplianceAseptic ProcessingQuality Management SystemsBilingual Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Manufacturing LeadershipAseptic ProcessingEquipment ValidationTroubleshootingProcess ControlAutomated Control SystemsQuality AssuranceBatch Record ReviewGood Documentation PracticesRegulatory Compliance

Soft Skills

Excellent CommunicationOrganizational SkillsDocumentation SkillsProblem-Solving SkillsTraining and Development

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Project

Industry Keywords

CGMPFDA RegulationsOSHAEPABiologics ManufacturingIGIV PurificationGxP StandardsCleanroom OperationsHealth and Safety ProtocolsBatch-Related Documents

Tech Stack

Tools & technologies

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About the role

Key responsibilities & impact

Lead and direct daily manufacturing shift activities, assign tasks, and follow up on progress
Ensure quality and preventive maintenance notifications are issued and investigated promptly
Ensure manufacturing schedules, products, and materials are delivered
Train IGIV Purification personnel on process, safety, and cGMP requirements
Identify technical and non-technical development gaps and implement plans and targets
Review safety cases and identify or implement corrective actions
Develop, train, and monitor personnel to ensure compliance with regulatory requirements, GCT procedures, and GxP standards
Ensure compliance with site operating procedures, health and safety protocols, and federal health authority regulations
Adhere to Good Documentation Practices
Coordinate and draft reviews of batch-related documents, including batch records and SOPs
Execute quality management system assignments, including CAPA, change control, and SOPs, and close them on time
Ensure equipment operates properly and request equipment or facility repairs and modifications
Resolve operational and equipment issues and coordinate emergency repairs, changes, and preventive maintenance with the Utilities team
Coordinate manufacturing activities with Quality Control, Materials Management, Quality Assurance, Validation, and other departments

Requirements

What you’ll need

CEGEP diploma or technical degree required
Previous experience in biologics protein IGIV purification manufacturing is an asset
1–3 years of manufacturing leadership or supervisory experience in a cGMP biopharmaceutical environment
Good understanding of the operating principles of most process equipment
Strong knowledge of the 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 validation
Ability to troubleshoot and maintain manufacturing systems, equipment, and processes
Ability to gown aseptically for cleanroom operations
Ability to react quickly to understand and resolve problems
Excellent communication, documentation, organizational, and troubleshooting skills
Ability to accurately read, understand, and follow company SOPs and guidelines
Good to excellent writing and computer skills
Proficiency in Microsoft Word, Excel, PowerPoint, and Project
Bilingual in French and English, both spoken and written; English proficiency required for documentation and communication with other Grifols sites outside Quebec and Canada
Bachelor of Science degree in Science, Engineering, or a related field preferred