Senior Pharmaceutical Process Engineer

Posted 3 days ago

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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.

Requirements

  • 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.

Benefits

  • A competitive salary
  • A comprehensive group insurance plan
  • A retirement savings plan
  • A bonus program
  • A wellness program
  • Access to continuous training and mentorship
  • A concrete commitment to work–life balance (Concilivi seal)
  • Structured and progressive career paths
  • A culture focused on innovation and technical excellence
  • An inclusive, collaborative and stimulating work environment
  • Health, safety and the environment at the core of our priorities

Job type

Full Time

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Flux

Location requirements

HybridQuebecCanada

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