Cleaning Validation Engineer
About the Job
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.
This position is responsible for the execution of cleaning validation activities at the Active Pharmaceutical Ingredient (API) manufacturing site of Agilent Technologies Nucleic Acid Solutions Division. Generate cleaning validation study documentation including protocols, new equipment acceptance forms, commissioning documentation, final reports and addenda while ensuring compliance with cGMP requirements. Execute cleaning validation studies in support of engineering, manufacturing, process development, facilities, quality control, and quality assurance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Generates, revises and executes documentation for cleaning validation studies ensuring compliance with QA and cGMP systems.
* Responsible for generating and executing cleaning validation protocols for new equipment.
* Responsible performing cycle development studies and resolving cleaning problems in manufacturing.
* Responsible for generating equipment characterization reports, including spray coverage testing.
* Required to support the cleaning validation schedule within the scope of ongoing projects.
* Support manufacturing, engineering, quality assurance, and quality control for cleaning and cleaning validation related activities.
* Support cleaning validation planning and support risk assessments associated with cleaning validation activities.
* Resolve CAPA's and change controls related to cleaning validation protocols.
* Support laboratory based cleaning validation studies, including but not limited to method validations and coupon studies.
* Responsible for the calibration of equipment supporting validation protocols and ensuring the calibration specifications for the equipment are appropriate.