Job summary We are seeking an experienced Validation Engineer to support validation activities, quality systems, and new product development within a regulated medical device environment. The ideal candidate will have hands-on experience with IQ/OQ/PQ, process andequipment validation, verification and validation (V&V), CAPA, root cause analysis,and process improvement. The candidate will collaborate with cross-functional teams and customers to ensure validation activities meet regulatory, quality, and business requirements.
Roles & Responsibilities:
Develop, review, and execute IQ, OQ, and PQ validation protocols for processes, equipment, systems, and software.
Prepare and maintain validation plans, protocols, reports, and supporting documentation.
Support process validation, equipment qualification, and verification & validation (V&V) activities.
Review validation documentation and identify compliance gaps, risks, and deficiencies.
Support CAPA investigations, root cause analysis (RCA), deviations, and corrective actions.
Identify and implement process improvements to improve quality, reliability, and efficiency.
Support FDA inspection readiness, audits, and quality system activities.
Perform statistical analysis of validation and process data using appropriate methods.
Use Minitab and statistical techniques, including P-value analysis, where applicable.
Collaborate with Quality, Engineering, Manufacturing, R&D, Operations, and other cross-functional teams.
Work with customers and internal stakeholders to manage validation projects, requirements, timelines, and deliverables.
Ensure validation activities comply with FDA regulations, ISO 13485, ISO 14971, and company quality procedures.
Maintain accurate and complete validation documentation in accordance with GMP/GDP and QMS requirements.
Education & Experience
Bachelor's degree in engineering, Science, or a related technical discipline.
Preferred disciplines include Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Chemical Engineering, Manufacturing Engineering, or Life Sciences.
3 5 years of validation experience in a regulated industry, preferably medical devices.
Hands-on experience with IQ/OQ/PQ and process/equipment validation.
Knowledge of FDA medical device regulations, ISO 13485, and ISO 14971.
Experience with CAPA, root cause analysis, deviations, and processimprovement.
Experience supporting verification and validation activities.
Numbers & Facts
Location
Irvine, CA
Skills
Biologyunmatched
Biomedical Engineeringunmatched
Chemical Engineeringunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Data Processingunmatched
Documentationunmatched
Electrical Engineeringunmatched
Equipment Validationunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Minitabunmatched
Process Analysisunmatched
Process Improvementunmatched
Process Validationunmatched
Product Developmentunmatched
Project/Program Managementunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Regulationsunmatched
Reliability Engineeringunmatched
Requirements Validation/Verificationunmatched
Research & Development (R&D)unmatched
Root Cause Analysisunmatched
Statisticsunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched
Value Analysisunmatched
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