CQV Supervisor

CA03 BioVectra Inc.; Windsor; On-site; CAD 89,000 - 138,000; Full time

Benefits offered by this job

Bonus

Stock options

Benefits

Job summary

Agilent Technologies Inc. in Windsor, Canada, is seeking a CQV Supervisor to lead the Facilities, Utilities and Equipment CQV program within our GMP environment.

You will guide engineering technicians, coordinate with multiple functions, and ensure systems remain validated throughout their lifecycle. The role emphasizes risk-based commissioning, qualification strategies, and lifecycle management for GMP facilities and equipment, with opportunities to drive continuous improvement and ensure

Qualifications

• Minimum three (3) years of relevant experience within pharmaceutical manufacturing or other GMP-regulated environments.
• Experience with commissioning and qualification, validation, or CQV lifecycle activities is an asset.
• Familiarity with GMP documentation and quality systems is preferred.

Responsibilities

• Lead Engineering's CQV program for facilities, utilities and equipment.
• Plan, coordinate and execute CQV activities across multiple projects and vendors.
• Support regulatory readiness and QA processes with CQV input and documentation.

Skills

CQV leadership

GMP knowledge

Technical writing

Cross-functional leadership

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Kneat

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 identifies 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 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.

Knowledge, Skills & Abilities

Strong understanding of GMP requirements and the ability to interpret regulatory expectations and apply them to practical CQV strategies and procedures. Knowledge of commissioning, qualification, validation of lifecycle principles, and pharmaceutical manufacturing systems. Strong technical writing, analytical, troubleshooting, and problem-solving skills. Ability to support technical investigations and develop practical, risk-based solutions. Strong organizational and planning skills with the ability to manage multiple priorities. Strong communication and interpersonal skills with the ability to work effectively across departments and provide technical leadership. Experience with electronic validation systems such as Kneat is considered an asset. Familiarity with FDA, Health Canada, ISPE, ASTM, GAMP, or other applicable industry guidance is considered an asset.

Working Conditions

Regular interaction within office, laboratory, manufacturing, warehouse, and utility environments. Occasional after-hours support may be required during commissioning, qualification, shutdowns, or other planned activities. Occasional travel may be required.

Leadership Competencies

• Accountability
• Emotional Intelligence
• Organizational Intelligence
• Cross-Functional Collaboration
• Develop Others
• Continuous Improvement
• Strategic Thinking
• Technical Leadership

Additional Details

This job has a full time weekly schedule. The full-time equivalent pay range for this position is $88,536.00 - $138,338.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Travel Required: Occasional Shift: Day Duration: No End Date Job Function: Manufacturing

As a global leader in laboratory and clinical technologies, we are passionate about bringing great science to life. Our commitment to quality and innovation supports cutting-edge life science research, patient diagnostics, and ensures the safety of water, food, and pharmaceuticals. As scientists and clinicians pursue small, everyday advances and life-changing discoveries, we provide trusted answers to their most critical questions and challenges. Leveraging more than 50 years of expertise, we create advanced instruments, software, and consumables supported by teams of highly skilled and knowledgeable people. With 18,000 employees around the world, our global reach and comprehensive solutions provide the most reliable and accurate results, as well as optimal scientific, economic, and operational outcomes. We work collaboratively with our customers on their journey to make a real difference in human lives. Our culture is founded on trust, respect, and uncompromising integrity, and we pride ourselves on being a dynamic and inclusive workplace that celebrates diversity and fosters innovation. We can’t wait for you to join us as we continue our mission to improve the world around us. Information about Agilent is available at Agilent.com.