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 actively creates change 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

Responsibilities

• Position Purpose

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 and 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.

Qualifications

Bachelors 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)

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

External Partners : Service providers, project-related contractors

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.

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