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…