CQV Supervisor

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. 
  

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