Validation Engineer
Katalyst HealthCares & Life Sciences
Job TitleIn 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 ResponsibilitiesDevelop 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.Required Qualifications8+ 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).
Vacancy posted 3 days ago
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