CQV Engineer - Process Support Equipment

Job Description

Job Description

Technical Source is hiring for an expansion in Holly Springs, North Carolina, We are proud to support the buildout of one of the most advanced biologics manufacturing sites in the world. This state-of-the-art facility is a strategic commitment to US-based manufacturing and innovation—and we're looking for top engineering talent to help bring it online.

We are actively seeking 10 experienced Commissioning & Qualification (C&Q) Engineers to support the startup and validation of upstream and downstream process equipment. This is a unique opportunity to work with cutting-edge systems and contribute directly to the qualification of large-scale bioprocessing platforms that will power the next generation of therapeutics.

As a C&Q Engineer at the Holly Springs site, you will:

• Drive commissioning and qualification of 2500L+ stainless steel bioreactors, integrating automation, sensors, and control platforms.
• Lead IQ/OQ/PQ protocols for 30cm+ chromatography columns, tangential flow filtration (TFF) systems, buffer / media prep skids, and associated automation.
• Execute testing and troubleshooting in collaboration with construction, CQV, automation, and quality teams.
• Support clean utility qualifications including WFI, clean steam, and compressed gases.
• Author and review critical documentation including test protocols, deviation reports, and turnover packages.

The Holly Springs site is built with flexible, modular design principles, supporting a multi-product biologics manufacturing model. Engineers joining this team will play a vital role in:

• Ensuring the commissioning integrity and GMP-readiness of flagship upstream and downstream platforms.
• Contributing to a project with long-term strategic importance.
• Supporting the mission to serve patients by building sustainable, high-performance operations from the ground up.
• Bachelor's degree in Mechanical, Chemical, or Biotech Engineering (or related field)
• 3 - 5 years of experience in biopharma equipment commissioning, startup, and qualification
• Deep knowledge of:
  • Large-scale bioreactors (2500L +)
  • Chromatography skids and columns 30cm diameter +.