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.