CQV Supervisor

Agilent; Windsor; On-site; CAD 90,000 - 130,000; Full time

Job summary

BIOVECTRA in Windsor, Nova Scotia seeks a CQV Supervisor to lead Facilities, Utilities and Equipment CQV programs, ensuring GMP systems remain validated and compliant throughout their lifecycle.

The role provides technical leadership to the Engineering Technician team and collaborates across Engineering, Manufacturing, Maintenance, Automation, Quality, Technical Operations, and external vendors to plan and execute CQV activities and drive continuous improvement.

Qualifications

• 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 or GMP environments.

Responsibilities

• Lead the Facilities, Utilities and Equipment CQV program to keep systems validated throughout their lifecycle.
• Develop and maintain CQV schedules, prioritise resources for manufacturing and projects.
• Plan, coordinate, and oversee commissioning, qualification, and lifecycle activities for GMP facilities and equipment.
• Review CQV documentation (IQ/OQ, plans, protocols, reports) and resolve discrepancies with stakeholders.
• Support CAPAs, change controls, investigations, and regulatory commitments related to CQV.

Skills

CQV Leadership

GMP Experience

Cross-functional

Education

Bachelor's degree in Engineering or related field

Job description

Job Description

Summary of Position

The CQV Supervisor is responsible for leading BIOVECTRA's Facilities, Utilities and Equipment Commissioning, Qualification and Validation (CQV) Program, ensuring GMP systems are appropriately commissioned, qualified, maintained in a validated state, and compliant throughout their operational lifecycle.

The position provides technical leadership to the Engineering Technician team and works cross-functionally with Engineering, Manufacturing, Maintenance, Automation, Quality, Technical Operations, and external vendors. The CQV Supervisor is responsible for CQV planning and execution, lifecycle management, inspection readiness, quality system support, and continuous improvement of Engineering's CQV program.

This position is focused on Facilities, Utilities and Equipment CQV and does not own Process Validation activities managed by Technical Operations or Quality.

CQV Program Leadership

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.

Commissioning, Qualification & Lifecycle Management

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.

Regulatory Compliance & Quality Systems

Monitors applicable regulatory guidance and industry practices and identify required improvements to Engineering's CQV procedures and programs.

Supports investigations, non-conformances, CAPAs, change controls, and risk assessments by providing CQV technical assessments and determining potential impacts to the qualified state.

Supports development and execution of remediation activities resulting from investigations, audits, CAPAs, or regulatory commitments.

Maintains CQV documentation and programs in an inspection-ready state and serves as an Engineering CQV subject matter expert during internal audits, customer audits, and regulatory inspections.

Collaborates with Technical Operations and Quality where Equipment & Facility CQV activities interface with Process Validation while maintaining clear ownership between the functions.

Leadership

Supervises, mentors, and develops Engineering Technicians responsible for commissioning, qualification, thermal mapping, and requalification activities.

Establishes priorities, assigns workload, provides technical guidance, and supports the professional development of team members.

Builds effective working relationships across Engineering, Manufacturing, Maintenance, Automation, Quality, Technical Operations, and external vendors.

Drives continuous improvement of CQV processes, execution practices, and program effectiveness.

Ensures activities are performed in accordance with GMP requirements, company procedures, and health and safety expectations.

Qualifications

Education

• 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.

Experience

• 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 q