Validation Specialist Job in Irvine 92620, California US
Validation Consultant
Responsibilities
•Maintains all documentation pertaining to cleaning cycle development and validation.
•Participates in cleaning cycle development activities for processing tanks including parameter selection, determining order of operations, troubleshooting, sampling, and data analysis.
•Coordinates validation execution between all involved departments.
•Independently follows-up and resolves comments, deviations, and technical issues.
•Authors development and validation protocols, SOPs, and reports.
•Reviews completed protocols for completeness, cGxP compliance and data acceptability; compiles final datapack.
•Reports progress and issues to team lead in an effective manner.
Requirements
•Bachelor’s degree or equivalent from accredited university in Engineering, Science, Computer Science, or technical discipline.
•5+ years of validation experience, with a strong emphasis in cleaning validation and cleaning cycle development.
•Knowledgeable in cGXP’s, validation principles, and change control.
•Proficient in the use of Microsoft Word, Excel, Visio and Outlook.
•Must be flexible to work all shifts, weekend work required.
•Experience with Kaye Validator instrumentation a plus.
Please respond with a copy of your resume to garima@ustechsolutions.com