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Validation Engineer

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ALTEN Technology USA

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Location:
United States , Irvine

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

95000.00 - 110000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field
  • 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
  • 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

Additional Information:

Job Posted:
February 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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