CQV Manager

EFOR; Geel; On-site; EUR 120,000 - 180,000; Full time

Job summary

EFOR is seeking a CQV Manager to lead commissioning, qualification, and validation for facilities, utilities, equipment, and processes, ensuring systems operate as intended and are ready for regulatory inspections.

You will drive planning, documentation, cross-functional collaboration, and risk management, mentoring engineers and coordinating with contractors to deliver compliant, production-ready assets.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
• Minimum 15 years of experience in CQV roles within regulated environments such as pharmaceuticals, biotechnology, or similar industries.
• In-depth knowledge of cGMPs, commissioning, qualification, validation methodologies, and regulatory requirements.
• Strong project management skills with a track record of successful CQV project execution.
• Excellent communication, leadership, and interpersonal skills.
• Problem-solving orientation and ability to work in fast-paced, dynamic environments.

Responsibilities

• Lead the development, management, and execution of CQV strategies and plans for new and existing projects.
• Oversee commissioning, qualification, and validation activities for facilities, utilities, equipment, and associated systems.
• Prepare, review, and approve CQV protocols, reports, and related documentation (DQ, IQ, OQ, PQ).
• Coordinate cross-functional teams, including project management, engineering, quality assurance, and operations, to ensure timely and compliant project delivery.
• Manage and mentor CQV engineers and third-party contractors, providing guidance and technical expertise.
• Ensure compliance with regulatory standards (e.g., FDA, EMA, GMP, GAMP, ISPE guidelines) throughout all CQV activities.
• Evaluate new equipment and system installations to ensure readiness and efficient integration into existing operations.
• Drive risk assessments (FAT, SAT, FMEA, etc.) and implement corrective and preventive actions as required.
• Support regulatory audits and inspections and respond to findings as required.
• Monitor, track, and report CQV project status, risks, and issues to stakeholders and senior management.

Skills

CQV expertise

Project management

Leadership

Communication

Problem solving

Education

Bachelor’s or Master’s degree in Engineering or Life Sciences

Job description

The CQV (Commissioning, Qualification, and Validation) Manager is responsible for managing, planning, and executing all activities related to the commissioning, qualification, and validation of facility, utilities, equipment, and processes in compliance with applicable regulatory requirements and industry standards. This role ensures that all systems operate as intended, are properly documented, and are ready for regulatory inspection and production.

Key Responsibilities:

• Lead the development, management, and execution of CQV strategies and plans for new and existing projects.
• Oversee commissioning, qualification, and validation activities for facilities, utilities, equipment, and associated systems.
• Prepare, review, and approve CQV protocols, reports, and related documentation (DQ, IQ, OQ, PQ).
• Coordinate cross-functional teams, including project management, engineering, quality assurance, and operations, to ensure timely and compliant project delivery.
• Manage and mentor CQV engineers and third-party contractors, providing guidance and technical expertise.
• Ensure compliance with regulatory standards (e.g., FDA, EMA, GMP, GAMP, ISPE guidelines) throughout all CQV activities.
• Evaluate new equipment and system installations to ensure readiness and efficient integration into existing operations.
• Drive risk assessments (FAT, SAT, FMEA, etc.) and implement corrective and preventive actions as required.
• Support regulatory audits and inspections and respond to findings as required.
• Monitor, track, and report CQV project status, risks, and issues to stakeholders and senior management.

Qualifications and Experience:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
• Minimum 15 years of experience in CQV roles within regulated environments such as pharmaceuticals, biotechnology, or similar industries.
• In-depth knowledge of cGMPs, commissioning, qualification, validation methodologies, and regulatory requirements.
• Strong project management skills with a track record of successful CQV project execution.
• Excellent communication, leadership, and interpersonal skills.
• Problem-solving orientation and ability to work in fast-paced, dynamic environments.