Validation Engineer

Technical Source is actively seeking a CQV Validation Engineer – Clean Utilities to support a high-profile greenfield pharmaceutical manufacturing project in Holly Springs, NC . This is a unique opportunity to work on the front end of a large-scale facility buildout, contributing to the design, commissioning, and qualification of clean utility systems in a state-of-the-art fill-finish environment.

Key Responsibilities:

• Lead and support CQV activities for clean utility systems such as WFI, Clean Steam, Compressed Gases, RO/DI Water, and Clean-in-Place (CIP) systems.
• Develop and execute commissioning, qualification, and validation (IQ/OQ/PQ) protocols in compliance with FDA, cGMP, and internal quality standards.
• Review and approve engineering design documents, FAT/SAT protocols, and equipment specifications.
• Interface with cross-functional teams including Engineering, QA, Facilities, and Manufacturing to ensure project milestones are achieved on time and within scope.
• Participate in risk assessments, change controls, and investigations related to utility systems.
• Ensure thorough documentation of validation activities and support inspections and audits as needed.

Required Qualifications:

• Bachelor’s degree in Engineering or related technical field.
• 5+ years of CQV or Validation experience in the pharmaceutical or biotech industry, with direct exposure to clean utility systems .
• Demonstrated experience on large-scale or greenfield projects is highly preferred .
• In-depth knowledge of cGMP regulations, FDA/ICH guidelines, and ISPE Baseline Guides.
• Strong technical writing, organization, and communication skills.