Job description
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.