Sr Process Engineer

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.

Technical \& Operational Support

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

Performance \& Process Optimization

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

Project Management \& Documentation

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

Qualifications

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

Experience

• Required
• Minimum 10 years of experience in the pharmaceutical industry, specifically in sterile injectable manufacturing.
• BS Engineering (or equivalent experience)