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Cleaning Validation Engineer

Job in Holly Springs, Wake County, North Carolina, 27540, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2025-12-01
Job specializations:
  • Engineering
    Validation Engineer, Quality Engineering, Pharma Engineer, Biomedical Engineer
Job Description & How to Apply Below

Overview

We are seeking a Cleaning Validation Engineer with hands-on experience in the startup and validation of clean utility systems such as Water Generation Systems (WFI/RO/DI), Clean Steam Systems, Process Gas/Air Systems, Distribution Systems, Storage Tanks, and CIP/COP Systems. This role involves working in a Greenfield facility with a high-paced validation environment focused on protocol development and cleaning lifecycle execution.

Responsibilities
  • Execute end-to-end Cleaning Validation lifecycle.
  • Specification and vendor document review.
  • Field verification and commissioning.
  • Protocol development and execution.
  • Summary and final report drafting.
  • Validate clean utility systems and equipment, including IVC washers, small parts washers, CIP skids, and process tanks.
  • Conduct and coordinate sample testing and tech rinses.
  • Support readiness for Phase II expansion (includes additional DSM buildings).
  • Work collaboratively in a team preparing the site for multi-product processing (cloning strategy across sites).
  • Manage and document work in compliance with GMP and regulatory standards.
  • Use Kneat software for digital validation lifecycle management.
  • Track approximately 800 cleaning circuits for upcoming validation work.
Qualifications
  • 210 years of direct experience in Cleaning Validation in a GMP environment.
  • Proficient with.
  • CIP/COP system validation.
  • Validation of clean steam, WFI, and compressed gas systems.
  • Familiarity with Kneat for electronic validation documentation.
  • Strong protocol writing and documentation skills.
  • Ability to work in a fast-paced, startup/Greenfield project environment.
  • Bachelor's degree in engineering, Life Sciences, or a related field preferred.
  • Required:

    410 years.
Seniority level
  • Mid-Senior level
Employment type
  • Contract
Job function
  • Industries
  • Pharmaceutical Manufacturing
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