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.

Qualifications

• Degree in engineering, life sciences, or a related technical field (., 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.