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Validation Engineer
Job in
San Jose, Santa Clara County, California, 95199, USA
Listed on 2026-07-19
Listing for:
Creative Solutions Services, LLC
Full Time
position Listed on 2026-07-19
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
Summary:
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 & 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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