Validation Engineer

Job Description

Job Description

We're ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more.

As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing.

When you join ALTEN Technology USA, you'll collaborate on some of the world's toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow.

About the Role

We are seeking a Validation Engineer II to join our pharmaceutical manufacturing team in Irvine, CA. In this role, you will be responsible for developing, executing, and closing Installation, Operational, and Qualification (IOQ) protocols for manufacturing equipment in a cleanroom environment. Your work will ensure compliance with cGMP and regulatory standards while supporting the production of high-quality finished products.

Responsibilities

• Author and execute IOQ protocols for manufacturing equipment and systems.
• Perform validation testing, analyze results, and document findings.
• Prepare and finalize IOQ reports in compliance with regulatory requirements.
• Support validation activities for equipment used in :
• Container finishing
• Automated leak testing
• Container packaging
• Work with manufacturing equipment such as :
• Pick & Place systems
• Conveyor systems
• Print & Apply labeling machines
• Collaborate with cross-functional teams to ensure timely completion of validation projects.
• Maintain compliance with FDA, EU, and internal quality standards.

Qualifications

Salary Range

ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity / expression or veteran status.

Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process.

Compliance Notice : Alten USA is a federal contractor subject to the requirements of the Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA) and Executive Order 11246. We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Drug Screening Requirement : As a federal contractor, Alten USA maintains a drug-free workplace. All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.