Katalyst CRO
Cleaning Validation Engineer
Katalyst CRO, Holly Springs, North Carolina, United States, 27540
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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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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