Process Validation Engineer

Position Overview

We are seeking a dedicated Process Validation Engineer with specialized expertise in Injection Molding to join our team on a 1-year contract supporting a leading Healthcare OEM client in Northridge, CA. Operating 100% onsite at the MiniMed facility, you will lead and execute process validation activities (IQ/OQ/PQ) for injection molded medical device components, ensuring full compliance with FDA regulations, ISO standards, and quality management systems.

Key Responsibilities

• Process Validation Execution: Develop, execute, and document IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols for plastic injection molding processes and associated equipment.

• Injection Molding Process Optimization: Tooling evaluation, mold flow analysis review, process parameter optimization, scientific molding principles, and window studies for medical grade components.

• Quality & Regulatory Compliance: Ensure all process validation deliverables strictly adhere to FDA 21 CFR Part 820 regulations, ISO 13485 quality standards, and internal quality procedures.

• Documentation & Technical Writing: Author detailed validation plans, protocols, summary reports, and standard operating procedures (SOPs).

• Root Cause Analysis & Troubleshooting: Perform failure analysis, root cause investigations, and implement Corrective and Preventive Actions (CAPA) for non-conformances identified during process validation.

• Cross-Functional Collaboration: Partner closely with Tooling, Quality, R&D, and Manufacturing Engineering teams to support production line setups and process improvements.

Required Qualifications & Skills

• Educational Background: Bachelor's degree in Mechanical Engineering, Industrial Engineering, Electrical Engineering, Automobile Engineering, Biomedical Engineering, or a closely related engineering field. (Note: Computer Science degrees will not be considered).

• Core Technical Expertise: Hands-on experience in process validation (IQ/OQ/PQ) specifically within Injection Molding and plastic processing applications.

• Industry Domain: Proven experience in a regulated industry, preferably Medical Devices or Healthcare manufacturing.

• Quality Standards: In-depth knowledge of FDA design controls, ISO 13485, GDP (Good Documentation Practices), and Risk Management (ISO 14971 / PFMEA).

• Work Authorization: (Mandatory due to client security policies).

• Location & Work Schedule: Must be fully available to work 100% onsite at the MiniMed facility in Northridge, CA.