Catalyx is seeking a Senior Process Engineer to provide technical problem-solving support for production equipment issues, offer technical support to manufacturing teams during operations, and works to reduce recurring equipment-related deviations. They also collaborate in responding to audit observations, customer requests, and other technical inquiries as needed.

Responsibilities

Technical & Operational Support

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Oversee the startup and optimization of new equipment.
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Provide technical support to manufacturing operations during execution.
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Participate in solving complex technical problems (troubleshooting).
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Design equipment modifications while meeting aseptic and operational requirements.
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Troubleshoot technical issues directly on production lines.
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Analyze machine downtime and recommend corrective actions.
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Participate in the commissioning of current equipment.

Performance & Process Optimization

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Improve key performance indicators (KPIs).
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Optimize production and maintenance processes.
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Develop and implement fast and effective troubleshooting solutions.
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Design and implement technical modifications to optimize equipment performance.
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Prepare control changes, procedures, and documentation required to implement improvements and solutions.

Project Management & Documentation

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Prepare intervention reports and technical procedures.
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Ensure compliance with safety and environmental regulations.
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Define project requirements and prepare feasibility studies.
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Communicate with equipment suppliers.
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Plan projects in coordination with Production, Engineering, Maintenance, Quality Assurance, and contractors to minimize production impact.
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Monitor project execution, including inspections, schedules, meetings, and communications.
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Ensure proper project closeout, including budgets, documentation, and change controls (CCs).
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Continuous Improvement & Leadership
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Use Lean and Six Sigma tools to analyze equipment utilization, labor efficiency, and machine performance to reduce waste and improve productivity.
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Provide leadership as a project manager.
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Participate in Continuous Improvement and Aseptic committees.
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Perform other administrative duties as assigned by the manager.

Requirements

Qualifications

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Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Chemical Engineering, Automation Engineering, or equivalent experience.
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Member of the Ordre des ingénieurs du Québec (OIQ).
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Minimum 10 years of experience in the pharmaceutical industry, specifically in sterile injectable manufacturing.
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Minimum 5 years of project management experience.
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Strong knowledge of aseptic manufacturing processes.
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Experience in equipment troubleshooting and modification (an asset).
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Strong analytical thinking, autonomy, customer service orientation, and interpersonal skills.
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Excellent analytical and technical problem-solving abilities.
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Strong knowledge of mechanical, electrical, and automated systems.
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Excellent communication and teamwork skills.
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Ability to manage multiple projects simultaneously.
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Ability to perform well under pressure and adapt to changing priorities.
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Bilingual in French and English, due to interactions with out-of-province suppliers.
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Strong communication skills and a sense of urgency in prioritizing work.
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Team-oriented with solid collaboration skills.
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Proficient in Microsoft Office tools, including AutoCAD, MS Project, and Visio.
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Knowledge of CAD and CMMS (Computerized Maintenance Management System) software.

Experience

Required

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Minimum 10 years of experience in the pharmaceutical industry, specifically in sterile injectable manufacturing.

BS Engineering (or equivalent experience)

📌 Sr Process Engineer (Canada)
🏢 Catalyx
📍 Canada