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.