Job Title: Validation EngineerJob 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).

ResponsibilitiesLead 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 SkillsBachelor’s degree in Engineering (Biomedical, Mechanical, Manufacturing, Chemical, Industrial, or related field).Minimum of 5 years of validation engineering experience in the medical device industry.Strong hands-on experience with equipment qualification (IQ/OQ/PQ).Demonstrated experience executing process validation in a regulated environment.Solid understanding of FDA QSR (21 CFR 820) and ISO standards.Experience remediating validation documentation in a post-acquisition or compliance-driven environment.Ability to work fully onsite in Irvine, CA.Strong technical writing and documentation skills.Ability to work independently and manage multiple remediation activities simultaneously.Additional Skills & QualificationsExperience with manufacturing processes such as assembly, molding, packaging, labeling, or sterilization support.Familiarity with risk management tools (e.g., PFMEA) as they relate to process validation.Experience supporting FDA inspections and/or notified body audits.Knowledge of statistical tools used in process validation.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: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

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

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.