CQV Engineer

Technical Source

CQV Engineer

Raleigh, NC
Full Time
Paid
  • Responsibilities

    As the new year approaches, Technical Source is anticipating the need for CQV Engineers to execute and support Commissioning, Qualification, and Validation (CQV) activities for large-scale pharmaceutical manufacturing projects in 2025! We will be looking for those that have hands-on experience in commissioning processes and a strong understanding of pharmaceutical manufacturing systems and operations.

    As a CQV Engineer, you will work closely with the project team to ensure that all equipment, systems, and utilities meet GMP standards and regulatory requirements before they enter production. You will be involved in protocol execution, system verification, and troubleshooting, with a focus on technical accuracy and compliance throughout the commissioning and validation process.

    Key Responsibilities:

    • Perform commissioning activities for new or modified equipment, systems, and facilities, ensuring all systems are installed, tested, and verified per design specifications and regulatory requirements.
    • Execute IQ/OQ/PQ protocols to validate equipment, facilities, and utilities, ensuring compliance with GMP and industry standards.
    • Prepare and review commissioning protocols and validation documents, ensuring technical accuracy and alignment with regulatory standards.
    • Conduct troubleshooting and system checks to resolve technical issues during commissioning and qualification phases.
    • Maintain accurate, audit-ready documentation for all CQV activities, supporting compliance with FDA, EMA, and other relevant regulatory bodies.