Manufacturing/Process Engineer

Job Summary (List Format):

- Lead and execute Test Method Validation (TMV) remediation activities.
- Develop, review, execute, and obtain approval for TMV protocols and final reports.
- Coordinate and perform validation testing, including sample preparation and test execution.
- Analyze and document validation results; resolve issues identified during validation.
- Apply statistical methods, including Gage R&R studies, to support validation conclusions.
- Support operator training to ensure consistent execution of validated test methods.
- Collaborate cross-functionally with Engineering, Quality, Manufacturing, and other stakeholders.
- Maintain validation documentation in compliance with quality-system requirements.
- Manage remediation schedule and drive TMV activities to timely completion.
- Utilize hands-on experience and expertise in validation lifecycle (protocols, execution, reporting).
- Employ strong technical writing, organizational, and communication skills in a regulated industry environment (medical device preferred).