Validation Engineer

We're hiring a Validation Engineer II to join our pharmaceutical manufacturing team in Irvine, CA. You'll ensure compliance and quality by developing, executing, and closing IOQ protocols for advanced manufacturing equipment in a cleanroom environment.

Requirements

• 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, and 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.

Benefits

• Comprehensive benefits
• Mentorship and career growth opportunities
• Equal opportunity employer