Job Description

ALTEN Technology USA is hiring a Validation Engineer II to join their pharmaceutical manufacturing team in Irvine, CA. The role involves developing, executing, and closing IOQ protocols for advanced manufacturing equipment in a cleanroom environment, ensuring compliance and quality with cGMP and FDA guidelines.

Responsibilities

• Develop and execute IOQ protocols for manufacturing equipment and automated systems
• Perform qualification activities on automated container handling systems, powder dosing equipment, and liquid filling machines
• Document results, manage deviations, and compile final reports
• Collaborate with Engineering, Manufacturing, and Quality teams
• Provide technical input during equipment design and change control processes

Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field
• 2–4 years of experience in equipment validation within a pharmaceutical or regulated manufacturing environment
• Familiarity with finished product manufacturing processes
• 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
• Detail-oriented, organized, and excellent communication skills

Benefits

• No benefits