Cleaning Validation Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Holly Springs, NC, 27540

Posted Date : 1 October 2025

Job Type : Other

Category : Mechanical Engineering

Occupation : Validation Engineer

Job Details

Job Description:
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.
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.

Requirements:

2-10 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.
bility to work in a fast-paced, startup/Greenfield project environment.
Bachelor's degree in engineering, Life Sciences, or a related field preferred.
Required: 4-10 years.