Cleaning Validation Engineer Job at Katalyst CRO in Holly Springs

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