Responsibilities

- Lead and direct daily manufacturing shift activities in the Fractionation production area, assigning tasks and following up on progress

- Ensure quality, safety, delivery, and productivity objectives are met

- Issue and investigate quality and preventive-maintenance notifications in a timely manner

- Ensure manufacturing schedules, products, and materials are delivered

- Train Fractionation manufacturing personnel on processes, safety, and cGMP activities

- Identify development gaps and implement applicable plans and targets

- Review safety cases and identify or implement corrective actions

- Develop, train, and monitor personnel to ensure compliant product manufacturing

- Ensure compliance with site procedures, health and safety protocols, and applicable federal health-authority regulations

- Coordinate and prepare reviews of batch-related documents, including batch records and SOPs

- Execute quality management system assignments, including CAPA and change control, and ensure timely closure

- Ensure equipment operates properly and request equipment or facility repairs and modifications as needed

- Resolve operational and equipment issues and coordinate emergency repairs, modifications, and preventive maintenance

- Coordinate manufacturing activities with Quality Control, Materials Management, Quality Assurance, Validation, and other departments

Requirements

- CEGEP diploma or technical degree required

- BS degree in Science, Engineering, or a related field preferred

- Previous experience in biologics protein fractionation manufacturing is an asset

- 1–3 years of manufacturing leadership/supervisory experience in a cGMP biopharmaceutical environment

- Good understanding of process equipment operating principles

- Strong knowledge of technical and scientific principles associated with aseptic processing

- Familiarity with automated control systems

- Knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations





- 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 respond quickly to assess and resolve problems

- Excellent communication, documentation, organizational, and troubleshooting skills

- Ability to accurately read, understand, and follow company SOPs and guidelines

- Strong writing and computer skills

- Proficiency in Microsoft Word, Excel, PowerPoint, and Project

- Bilingual in spoken and written French and English; English required for documentation and communication with other Grifols sites

Core Competencies

Demonstrates expertise in leading manufacturing operations within a cGMP biopharmaceutical environment, ensuring compliance with safety and quality standards while effectively training and developing personnel. Proficient in troubleshooting manufacturing systems and equipment, with a solid understanding of aseptic processing and regulatory requirements.

Highest-signal resume keywords

- Manufacturing Leadership

- CGMP Compliance

- Aseptic Processing Knowledge

- Quality Management Systems

- Bilingual Communication

ATS Optimization Keywords

Hard Skills

- Manufacturing Leadership

- CGMP Knowledge

- Aseptic Processing

- Troubleshooting

- Process Control

- Equipment Validation

- Batch Record Review

- Preventive Maintenance

- Automated Control Systems

- Statistical Analysis

Soft Skills

- Excellent Communication

- Organizational Skills

- Documentation Skills

- Problem-Solving Skills

- Training and Development

Industry Keywords

- Biopharmaceutical

- FDA Regulations

- OSHA Compliance

- EPA Regulations

- CGMP Standards

- Cleanroom Operations

- Quality Control

- Quality Assurance

- Materials Management

- Validation

Tools & Technologies

- Microsoft Word

- Microsoft Excel

- Microsoft PowerPoint

- Microsoft Project

📌 Fractionation Manufacturing Supervisor (Montreal)
🏢 Jobtailor
📍 Montreal