Job: Manufacturing/Process Engineer w Test Method Validation Expertise
LOCATION Hybrid Irvine, CA
DURATION 6-8 + months
INTERVIEW TYPE 2 Rounds
VISA RESTRICTIONS NONE
Key Responsibilities
Lead and execute TMV remediation activities.
Develop, review, execute, and support approval of TMV protocols and final reports.
Coordinate and perform validation testing activities, including sample preparation and test execution.
Analyze and document validation results and support resolution of issues identified during execution.
Apply statistical methods including Gage R&R studies to support validation conclusions.
Support operator training to ensure consistent execution of validated test methods.
Work cross-functionally with Engineering, Quality, Manufacturing, and other stakeholders.
Maintain validation documentation per quality-system requirements.
Support remediation schedule and drive TMV activities to completion.
Required Experience
Hands-on experience executing TMV activities.
Full validation lifecycle experience (protocols, execution, reporting).
Strong statistical analysis experience including Gage R&R.
Regulated industry experience (medical device preferred).
Strong technical writing and documentation skills.
Ability to independently execute validation activities.
Cross-functional collaboration experience.
Strong organizational and communication skills.
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