Equipment Qualification Engineer

Responsibilities

• Serve as a subject matter expert for qualification and commissioning activities.
• Lead all phases of qualification:
  Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification execution, and close‑out.
• Ensure alignment with internal validation standards and regulatory expectations.
• Partner with cross‑functional teams (MS&T, QA, Engineering, Operations, vendors) to ensure seamless execution of qualification deliverables.
• Prepare, review, and approve qualification documentation such as plans, protocols, and reports.
• Support Computerized System Validation (CSV) where applicable.
• Investigate deviations, manage change controls, and oversee corrective/preventive actions related to equipment qualification.
• Participate in audit preparation and act as SME during inspections.

• Degree in engineering, life sciences, or a related technical field (e.g., mechanical, chemical, or process engineering).
• At least 5 years of experience in equipment qualification and validation in a GMP-compliant pharmaceutical or biotech environment.
• Solid understanding of qualification processes and documentation standards.
• Proven experience managing complex technical deliverables and collaborating across teams.
• Strong communication skills, with the ability to document clearly and influence stakeholders.
• Fluency in English;
  French is an asset.
• Previous experience supporting regulatory audits is considered a plus.