Senior Process Engineer

Catalyx; Montreal (administrative region); On-site; CAD 110,000 - 160,000; Full time

Job summary

Catalyx is seeking a Senior Process Engineer to support production equipment issues and manufacturing operations. The role focuses on reducing recurring deviations, responding to audits, and driving continuous improvement in aseptic processes.

The ideal candidate has extensive experience in the pharmaceutical industry, strong project management skills, and proficiency with AutoCAD, MS Project, Visio, and CMMS. Bilingual French-English is valued for supplier interactions.

Qualifications

• Bachelor's degree in engineering or equivalent required.
• 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.
• Proficient in AutoCAD, MS Project, Visio, and CMMS.

Responsibilities

• Oversee the startup and optimization of new equipment.
• Provide technical support to manufacturing operations during execution.
• Design equipment modifications meeting aseptic and operational requirements.
• Analyze machine downtime and recommend corrective actions.
• Lead project planning with Production, Engineering, Maintenance, QA, and contractors to minimize production impact.
• Apply Lean and Six Sigma tools to analyze equipment utilization, labor efficiency, and machine performance to reduce waste and improve productivity.

Skills

Project management

Lean Six Sigma

Troubleshooting

Analytical thinking

Teamwork

Bilingual French-English

Education

Bachelor's degree in Mechanical, Electrical, Industrial, Chemical, Automation Engineering or equivalent

Tools

AutoCAD

MS Project

Visio

CMMS

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).
• 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.
• 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.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them.

• The team in Catalyx benefits from a Total Rewards package.
• This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create awelcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.