Job Description

ALTEN Technology USA is seeking a Validation Engineer II to join their pharmaceutical manufacturing team in Irvine, CA. The role involves developing, executing, and closing Installation, Operational, and Qualification (IOQ) protocols for manufacturing equipment in a cleanroom environment, ensuring compliance with cGMP and regulatory standards.

Responsibilities

• Author and execute IOQ protocols
• Perform validation testing and analyze results
• Prepare and finalize IOQ reports
• Support validation activities for container finishing, leak testing, and packaging equipment
• Work with pick & place, conveyor, and print & apply systems
• Collaborate with cross-functional teams
• Maintain compliance with FDA, EU, and internal quality standards

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

Benefits

• No benefits