Validation Engineer II - Lab & Process Equipment
Job Description
Job 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.
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