Validation Engineer

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’re hiring a Validation Engineer II to join our pharmaceutical manufacturing team in Irvine, CA. In this role, you’ll ensure compliance and quality by developing, executing, and closing IOQ (Installation, Operational, Qualification) protocols for advanced manufacturing equipment in a cleanroom environment. You’ll work with cutting-edge technologies and collaborate with a team committed to innovation and excellence.

Responsibilities

• Develop and execute IOQ protocols for manufacturing equipment and automated systems in compliance with cGMP and FDA guidelines.
• Perform qualification activities on:
• Automated container handling systems
• Powder dosing equipment
• Liquid filling machines
• Document results, manage deviations, and compile final reports in accordance with SOPs and regulatory requirements.
• Collaborate with Engineering, Manufacturing, and Quality teams to support equipment qualification and troubleshooting.
• Provide technical input during equipment design and change control processes.

Qualifications

• Education: Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field.
• Experience:
• 2–4 years in equipment validation within a pharmaceutical or regulated manufacturing environment.
• Familiarity with finished product manufacturing processes, including automated container handling, powder dosing, and liquid filling.
• Skills:
• Strong knowledge of cGMP and FDA guidelines.
• Proficiency in protocol writing, execution, and report generation.
• Ability to work in cleanroom environments and follow aseptic practices.
• Attributes: Detail-oriented, organized, and excellent communication skills.

Salary Range

• $95,000 - 110,000
• The actual salary offered is dependent on various factors including, but not limited to, location, the candidate’s combination of job-related knowledge, qualifications, skills, education, training, and experience 

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.