About the role

Senior Engineer specializing in pharmaceutical processes for EXP, focusing on project design and compliance. Collaborating with clients and optimizing processes for regulated environments.

Responsibilities

Design, develop and optimize pharmaceutical processes from conceptual study through to commercial production.
Establish design bases and define process philosophies in compliance with regulatory requirements.
Develop, review and approve process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs) and functional schematics, ensuring consistency with quality requirements.
Perform mass and energy balances, capacity analyses and process performance evaluations.
Select, size and specify critical equipment (reactors, bioreactors, CIP/SIP systems, filtration, etc.) and dedicated utilities (purified water, clean steam, clean compressed air, etc.).
Ensure integration of cleaning, sterilization and containment requirements (cleanrooms, personnel and material flows, zoning, biosafety).
Prepare technical deliverables, design bases, specifications, drawings and bills of materials, engineering reports and technology transfer documentation.
Supervise engineering activities, ensuring multidisciplinary coordination.
Actively participate in commissioning, qualification and validation phases of processes.
Serve as a technical expert to clients, contributing to the resolution of critical issues and optimizing operational performance.

Bachelor’s degree in chemical engineering, biotechnology engineering, process engineering or a related discipline.
Registered member in good standing with the Ordre des ingénieurs du Québec (OIQ).
10–15 years of relevant experience in pharmaceutical processes within consulting engineering.
Strong knowledge of regulated environments: GMP, FDA, Health Canada, EMA, ISPE.
Experience in the design of sterile processes, biopharmaceutical manufacturing or other regulated product manufacturing.
Deep understanding of CQV practices (Commissioning, Qualification & Validation).
Strong analytical, organizational and problem‑solving skills for complex issues.
Excellent communication and influencing skills, with proven ability to act as a technical leader for clients and teams.
Strategic mindset, rigor, autonomy and a strong sense of responsibility in demanding environments.
Inspirational leadership with the ability to coach and develop teams.