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.