What are the responsibilities and job description for the Validation Engineer position at Technical Source?
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.
