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Senior Cleaning Validation Consultant

Staftonic LLC · New York, United States

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Senior Cleaning Validation Consultant

Location: New York Long-Term Project Role Summary:Seeking an experienced CIP Development & Cleaning Validation Consultant to support biologics manufacturing, including mAb process equipment and CIP systems.

The consultant will perform cleaning studies, support CIP cycle development, execute cleaning validation, and troubleshoot cleaning performance in a GMP environment.Note: NO C2C – W2 ONLYKey Requirements:5+ years of experience in cleaning validation, CIP development, process validation, or related pharma/biotech engineering.Hands-on experience with TOC swab and rinse sampling.Experience with cleanability and degradation studies.Strong experience in CIP cycle development, optimization, and troubleshooting.Experience executing cleaning validation protocols in GMP manufacturing.Biologics manufacturing experience required; mAb experience preferred.Experience with process vessels, CIP skids, stainless-steel equipment, and cleaning systems.Familiarity with upstream/downstream operations, including cell culture, chromatography, and TFF, is a plus.Bachelor’s degree in engineering, chemistry, biology, life sciences, or a related field.Preferred: Startup/commissioning/qualification experience and exposure to LabWare, Veeva, or similar systems.