Senior CSV Specialist: Validation & Compliance Expert
Job in
Durham, Durham County, North Carolina, 27703, USA
Listed on 2026-07-08
Listing for:
KBI Biopharma, Inc.
Full Time
position Listed on 2026-07-08
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
KBI Biopharma, Inc. in Durham, North Carolina is looking for a CSV Specialist to support all aspects of the Computer Systems Validation (CSV) Lifecycle. You will be responsible for authoring protocols and test scripts, ensuring compliance with regulations, and maintaining validation documentation.
The ideal candidate will hold a Bachelor’s degree in Engineering or a related field and have 3–5 years of industry experience, particularly with GAMP and 21 CFR Part
11 compliance. Strong problem-solving skills and proficiency in Microsoft Office are essential.
Position Requirements
10+ Years
work experience
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