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Validation Engineer

Job in Lexington, Fayette County, Kentucky, 40598, USA
Listing for: Shoolin Inc
Full Time position
Listed on 2026-02-28
Job specializations:
  • Engineering
    Validation Engineer, Pharma Engineer, Biomedical Engineer, Quality Engineering
  • Pharmaceutical
    Validation Engineer, Pharma Engineer, Quality Engineering
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

Seeking a Validation Engineer with experience in pharmaceutical or biotechnology manufacturing environments. The role will support equipment, process, cleaning, and computerized system validation activities in compliance with regulatory requirements.

Required Experience:
  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • 2+ years of validation experience in Pharma/Biotech industry
  • Experience in IQ, OQ, PQ execution and documentation
  • Knowledge of cGMP and FDA regulations
  • Experience with validation protocol/report writing
  • Exposure to process, cleaning, equipment, or CSV validation
Key Responsibilities:
  • Develop, review, and execute validation protocols (IQ/OQ/PQ)
  • Prepare validation reports and summary documentation
  • Support equipment qualification and process validation activities
  • Ensure compliance with cGMP, FDA, and regulatory requirements
  • Collaborate with QA, Manufacturing, and Engineering teams
  • Assist in deviation investigations and CAPA related to validation activities
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