Validation Engineer

ALTEN Technology USA•Irvine, CA

87d•$95,000 - $110,000•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field.
3+ years in pharmaceutical or biotech validation.
Familiarity with finished product manufacturing processes.
Hands-on experience with container finishing, leak testers, and packaging equipment.
Strong understanding of cGMP and regulatory guidelines.
Ability to work in a cleanroom environment and follow aseptic procedures.

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.