Validation Engineer

Job Title : Validation Engineer Job Description

We are seeking an experienced Validation Engineer to support post-acquisition remediation efforts at our Irvine, CA facility. This fully onsite role will focus on the remediation, execution, and documentation of equipment qualification and process validation activities to ensure compliance with regulatory requirements and internal quality standards. The ideal candidate has strong hands-on experience with IQ / OQ / PQ, medical device manufacturing processes, and working in compliance-driven environments. This role requires the ability to independently assess legacy validation documentation, identify gaps, and drive remediation activities to completion as part of integrating an acquired company into a corporate Quality Management System (QMS).

Responsibilities

• Lead and execute equipment qualification remediation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform process validation remediation for manufacturing processes in accordance with FDA and ISO requirements.
• Assess legacy validation documentation from the acquired company, identify gaps, and develop remediation plans.
• Author, review, and approve validation protocols, reports, and supporting documentation.
• Ensure validation activities comply with FDA QSR (21 CFR 820), ISO standards, and internal SOPs.
• Collaborate cross-functionally with Manufacturing Engineering, Quality, Operations, R&D, and Regulatory Affairs to define validation strategies and acceptance criteria.
• Support validation activities for new, existing, and transferred equipment and processes.
• Ensure validation deliverables are properly documented and controlled through change management processes.
• Support internal and external audits, inspections, and remediation-related assessments.
• Provide technical input for deviations, nonconformances, CAPAs, and risk assessments related to validated processes.
• Identify opportunities to improve validation processes and ensure long-term compliance and sustainment.

Essential Skills

Additional Skills & Qualifications

Work Environment

This position is fully onsite with core hours from 8 AM to 5 PM. Employees enjoy 3 weeks of PTO and 10 paid holidays, contributing to a balanced work-life experience.

Job Type & Location

This is a Contract position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $60.00 - $70.00 / hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Feb 19, 2026.