Validation Engineer
Job in
San Jose, Santa Clara County, California, 95112, USA
Listed on 2026-07-19
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-07-19
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Validation Engineer, Medical Device Industry
Job Description & How to Apply Below
Job Title
In this position, you will be responsible for the planning, execution, and documentation of validation protocols (IQ/OQ/PQ) for medical device manufacturing processes and equipment. You will work cross-functionally to ensure the products meet the highest quality standards.
Roles and Responsibilities- Develop and execute validation plans and reports.
- Analyze data and troubleshoot process deviations.
- Ensure compliance with FDA regulations and ISO standards.
- Collaborate with Engineering and Quality teams to drive continuous improvement.
- 8+ years of validation experience in the medical device or other regulated industry.
- Strong expertise in injection molding and plastic materials.
- Hands-on experience with cleaning validation and contamination control.
- Solid understanding of the validation lifecycle (IQ/OQ/PQ) and statistical analysis.
- Familiarity with FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
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