CQV Supervisor

Description

• Leads Engineering's Facilities, Utilities and Equipment CQV Program and ensures qualified systems remain in a validated state throughout their operational lifecycle.
• Develops and maintains the Equipment & Facility CQV schedule, establishing priorities and coordinating resources to support manufacturing, capital projects, requalification activities, and regulatory commitments.
• Establishes appropriate commissioning and qualification strategies based on system criticality, intended use, risk, regulatory expectations, and company procedures.
• Maintains Engineering CQV procedures, standards, templates, and practices and ensures they remain aligned with current regulatory expectations and industry best practices.
• Plans, coordinates, and oversees commissioning, qualification, periodic requalification, and lifecycle activities for GMP facilities, utilities, manufacturing equipment, laboratory equipment, and associated systems.
• Develops, reviews, and approves CQV documentation including validation plans, IQ/OQ protocols, thermal mapping protocols, technical assessments, deviations, and summary reports.
• Provides technical oversight for thermal validation activities including SIP, autoclaves, controlled temperature units, refrigerators, freezers, incubators, environmental chambers, and other applicable systems.
• Reviews qualification results, investigates discrepancies or failures, and works with appropriate stakeholders to determine resolution and required follow-up actions.
• Supports capital projects and equipment modifications by identifying and coordinating required commissioning and qualification activities.

Qualifications

Highest qualification: University

• Bachelor's degree in Engineering, Biotechnology, Biological Sciences, Food Science, Chemistry, Pharmaceutical Sciences, Life Sciences, or related technical discipline.
• An equivalent combination of education and relevant technical or GMP experience may be considered.
• Minimum three (3) years of relevant experience within pharmaceutical manufacturing, biotechnology, or another regulated GMP environment.
• Experience in one or more of the following areas: commissioning and qualification, validation, Technical Operations, manufacturing support, engineering, quality systems, or other related technical functions.
• Demonstrated experience working with GMP documentation and quality systems such as investigations, deviations, CAPAs, change controls, or risk assessments.
• Experience with equipment qualification, IQ/OQ, thermal validation, or CQV lifecycle activities is considered an asset.
• Previous supervisory, team leadership, or project leadership experience is considered an asset.
• Proficient with Microsoft Office Suite applications.