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.

Responsibilities

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.

Requirements

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.