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Validation Engineer

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IT Minds LLC

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Location:
United States , Ashburn

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

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Job Description:

We are seeking a skilled Validation Engineer to join our team. The ideal candidate will be responsible for developing and implementing validation protocols and ensuring compliance with FDA regulations and internal quality standards.

Job Responsibility:

  • Prepare Validation Master Plans and author validation protocols (IQ, OQ, PQ) in accordance with FDA regulations
  • Execute validation activities and manage associated processes, including change controls, CAPA, and deviation records
  • Monitor and ensure data integrity
  • compile and analyze data for summary reports and trend analysis
  • Support regulatory audits and internal self-inspections
  • Ensure compliance with applicable Standard Operating Procedures (SOPs) and quality requirements

Requirements:

  • Bachelor’s degree in Science, Technology, Engineering, or related field
  • Minimum 5 years of experience in validation or a related occupation
  • Strong understanding of FDA regulations and cGMP requirements
  • Experience with CAPA systems, deviation handling, and audit readiness is preferred
  • Excellent analytical, documentation, and communication skills

Nice to have:

Experience with CAPA systems, deviation handling, and audit readiness

Additional Information:

Job Posted:
December 09, 2025

Employment Type:
Fulltime
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