Job Title: Validation Engineer

Location: Irvine, CA (Onsite)

Overview:

Seeking a Validation Engineer with strong medical device experience to lead equipment qualification and process validation remediation activities. The role focuses on ensuring compliance with regulatory standards and supporting validation efforts within a quality-driven environment.

Required Experience:

• 5+ years of validation engineering experience in the medical device industry
• Hands-on experience with equipment qualification (IQ/OQ/PQ)
• Experience executing process validation in a regulated environment
• Strong knowledge of FDA 21 CFR 820 and ISO 13485
• Experience with validation documentation remediation and gap assessments
• Strong technical writing and documentation skills

Key Responsibilities:

• Execute and support equipment qualification (IQ/OQ/PQ) and process validation activities
• Assess legacy validation documents, identify gaps, and drive remediation plans
• Author, review, and approve validation protocols and reports
• Ensure compliance with FDA and ISO standards and internal procedures
• Collaborate with cross-functional teams (Manufacturing, Quality, R&D, Regulatory)
• Support validation for new, existing, and transferred equipment/processes
• Assist with audits, inspections, CAPAs, and risk assessments