Validation Engineer II Lab Process Equipment

Overview

Technical Source is hiring a hands-on Validation Engineer to support commissioning and qualification activities at a rapidly growing biotech manufacturing site in Durham. This is not a paper-pusher role, we’re looking for someone who can be in the field, write solid protocols, execute IQ/OQ, and drive equipment to operational readiness.

If you’ve validated lab equipment, supported cleaning validation, and know your way around cGMP documentation, keep reading.

• Writing and executing IQ/OQ protocols

• Supporting equipment startup, FAT/SAT, and commissioning

• Redlining and developing URS / FRS / DDS documentation

• Driving lifecycle documentation through approval

• Supporting change control, deviations, and CAPAs

• Working side-by-side with Engineering, QA, Manufacturing, and Vendors

• Ensuring compliance with 21 CFR 210, 211, and Part 11

• Autoclaves, incubators, refrigerators, freezers

• Parts washers & cleaning validation

• Lab and QC equipment

• General biotech manufacturing equipment

• 3+ years of validation experience in a biotech or pharmaceutical environment

• Strong hands-on IQ/OQ execution experience

• Solid understanding of FDA validation expectations & GDP

• Comfortable being onsite and in the field

• Clear communicator who can keep projects moving

• High-visibility project inside a growing biotech operation

• Opportunity to convert to full-time

• Competitive hourly pay

• Work on real startup equipment, not maintenance paperwork

This is ideal for a validation engineer who wants to grow beyond execution and gain exposure to full project lifecycle validation.