Job Information
Actalent Validation Engineer in Irvine, California
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.
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) 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
Bachelor’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 risk management.
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 & Qualifications
Experience 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 at our Irvine, CA facility, with core hours from 8 AM to 5 PM. The role offers 3 weeks of PTO and 10 paid holidays. The work environment is compliance-driven and supports collaboration across various departments, including Manufacturing Engineering, Quality, Operations, R&D, and Regulatory Affairs.
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 Mar 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.