Engineering Validation Specialist

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

Job Description

Job Title: Validation Specialist – Engineering
Reports to: Director of Engineering
Number of Direct Reports: 0

The role of the Validation Specialist is to prepare qualification documentation (IQ/OQ) for equipment and utilities, document changes made to equipment and utilities, and maintain calibration records for measuring instruments used by the building mechanical systems department.

• Prepares the annual SVMP for their sector (Engineering)

• Prepares qualification documentation for equipment and utility systems (HVAC, control systems (DDC), compressed air, purified water, etc.)

• Coordinates documentation related to calibration of utility equipment

• Coordinates documentation related to calibration of measuring instruments used by the building mechanical systems team

• Coordinates and oversees the work of external contractors during HEPA filter certification testing

• Coordinates and oversees the work of external contractors during scale certification testing (manufacturing, packaging, warehouse, QA)

• Supports the instrument calibration program and coordinates calibration tasks for equipment to ensure timelines are met

• Participates in the planning, organization, and execution of projects related to building mechanical equipment

• Provides support during equipment start-up and operation

• Ensures execution of all tasks under their responsibility for equipment qualification in compliance with GMP, HSE, and other equipment-specific regulatory standards

• Ensures AutoCAD drawings are updated when new equipment is installed or when modifications are made to equipment and/or utility systems

Under the supervision of the Director of Engineering, the Validation Specialist performs qualification work for new equipment and utilities. The role supports calibration activities for utility equipment and is responsible for coordinating the work of certain contractors and ensuring compliance with applicable standards. This position has no direct supervisory responsibilities.

Internal Partners: Production, Engineering Projects, HSE, Quality, Purchasing

External Partners: Service providers, project-related contractors

Bachelor's degree in Science or Engineering, or equivalent relevant experience

French and English

• 5 to 10 years of experience in validation

• Knowledge of HVAC and control systems

• Knowledge of purified water systems

• Knowledge of Canadian standards

• Knowledge of the pharmaceutical industry

• Automation / industrial IT

• Energy and fluids (air, water, etc.)

• HSE

• GMP (Good Manufacturing Practices)

We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.