Cleaning Validation Engineer
Cleaning Validation Engineer
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Salary Not Disclosed
1 Vacancy
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.
- 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.
- Ability to work in a fast-paced startup/Greenfield project environment.
- Bachelors degree in engineering Life Sciences or a related field preferred.
- Required: 4 10 years.
Employment Type
Full Time
