Validation Engineer III

Our client, a leader in the medical device industry, is seeking a Validation Engineer III to join their team. As a Validation Engineer III, you will be part of the Quality Assurance Department supporting validation activities across multiple projects. The ideal candidate will demonstrate strong technical expertise, excellent communication skills, and a proactive approach to problem-solving, which will align successfully within the organization.

Validation Engineer III

San Diego, CA

$39/hr on W2

• Lead and execute validation protocols for equipment, processes, and systems in compliance with FDA, ISO 13485, and other relevant standards.
• Develop and maintain validation documentation including URS, FRS, DRS, FAT, DQ, IQ, OQ, PQ, PV, and related reports.
• Perform risk assessments, gap analyses, and support continuous improvement initiatives within the Quality Management System.
• Support internal and external audits by providing validation documentation and technical expertise.
• Manage validation projects, develop timelines, and communicate project status to stakeholders effectively.

• Bachelor's degree in Engineering, Biology, Chemistry, or a related science field.
• At least 5 years of experience in validation within the medical device or related industry.
• Proficiency in equipment qualification (IQ/OQ/PQ), process validation, and computer system validation.
• Strong understanding of FDA regulations, ISO standards, and Good Documentation Practices.
• Excellent problem-solving, organizational, and communication skills, with the ability to work independently and collaboratively.

• Opportunity to work in a dynamic, innovative environment supporting life-changing diagnostics.
• Chance to contribute to high-quality validation processes and ensure compliance with industry standards.
• Collaborate with a diverse team of experts committed to excellence and continuous improvement.
• Engage in meaningful projects that impact patient health and safety.
• Be part of a company that values diversity, inclusion, and professional growth.