Process Validation Engineer

Job Description

Job Description

We are seeking a skilled Process Validation Engineer for a short-term contract position ending in March. The role involves performing process and test method validation activities for medical device manufacturing processes, ensuring compliance with regulatory and quality standards.

Responsibilities

• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing processes.
• Validate processes including resistance welding, ultrasonic welding, soldering, and adhesive bonding to meet product and quality specifications.
• Conduct Test Method Validation (TMV) and Gage Repeatability and Reproducibility (Gage R&R) studies to ensure measurement system reliability.
• Utilize and validate standard measuring tools, including drop gauges, go / no-go gauges, calipers, micrometers, and microview systems.
• Collaborate with cross-functional teams to ensure validation activities align with project timelines and quality requirements.
• Troubleshoot validation issues and implement corrective actions to maintain process integrity.
• Document validation activities and maintain accurate records in accordance with regulatory and organizational standards.

Qualifications

Location

Employment Type

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

Equal Opportunity Employer Minorities / Women / Veterans / Disabled