Validation Manufacturing/Process Engineer

ZETTALOGIX INC; Irvine (CA); Hybrid; USD 95,000 - 125,000; Full time

Job summary

ZETTALOGIX INC. is seeking a Manufacturing/Process Engineer with TMV expertise to drive remediation and validation activities in Irvine, CA.

You will manage the full TMV lifecycle from protocol development to final reports and support cross-functional teams across Engineering, Quality, and Manufacturing. Applicants should have hands-on TMV execution, strong statistical analysis including Gage R&R, and excellent technical writing.

Qualifications

• Hands-on TMV execution required.
• Full validation lifecycle experience (protocols, execution, reporting).
• Strong statistical analysis including Gage R&R.
• Regulated industry experience preferred (medical device).
• Strong technical writing and documentation skills.

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 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.

Skills

TMV remediation

Statistical analysis

Gage R&R

Cross-functional collaboration

Documentation

Job description

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.