Validation Engineer II - Lab & Process Equipment in Durham

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Job DescriptionJob Description

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.

What You'll Be Doing

• 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

Equipment You Should Be Comfortable With

• Autoclaves, incubators, refrigerators, freezers

• Parts washers & cleaning validation

• Lab and QC equipment

• General biotech manufacturing equipment

What We're Looking For

• 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

Why This Role?

• 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.

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.