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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:

The Validation Engineer II is responsible for planning, executing, and closing Installation and Operational Qualification (IOQ) activities for critical facility and utility systems within a pharmaceutical manufacturing environment. This includes system-level qualification of cleanrooms, utilities, and integrated manufacturing systems to ensure compliance with regulatory standards and internal quality requirements.

Job Responsibility:

  • Develop and execute IOQ protocols for facility and utility systems such as Water for Injection (WFI), clean steam, nitrogen/compressed air gases, and cleanroom environments
  • Author detailed qualification protocols and ensure alignment with regulatory and company standards
  • Perform qualification activities in cleanroom environments, document results, and manage deviations and corrective actions
  • Compile and finalize qualification reports, ensuring traceability and compliance with GMP and validation standards
  • Work closely with engineering, operations, and quality teams to maintain validated state of systems
  • Ensure adherence to FDA, EMA, and ICH guidelines for system-level validation
  • Identify opportunities for improving qualification processes and system reliability

Requirements:

  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • 3–5 years of validation experience in pharmaceutical or biotech manufacturing
  • Hands-on experience with system-level qualification of critical utilities and cleanroom environments
  • Strong understanding of GMP, FDA, and ICH guidelines
  • Proficiency in writing and executing IOQ protocols and reports
  • Ability to work in cleanroom environments and adhere to gowning procedures
  • Excellent documentation and communication skills
  • Strong analytical and problem-solving abilities

Nice to have:

  • Experience with integrated manufacturing systems and risk-based validation approaches
  • Familiarity with computerized systems validation and data integrity principles

Additional Information:

Job Posted:
February 16, 2026

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