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.
