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.

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.