Validation Engineer

EPM Scientific
Nebraska, Estados Unidos
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responsible for :

  • Perform lab-scale processing and / or data analysis review
  • Lead the development and implementation of Change Controls, Deviation investigations and CAPAs
  • Execute Installation / Operational / Process Qualification / Process Validation (IQ, OQ, PQ, PV) protocols
  • Support the Validation Master Plan and Calibration program activities
  • Identify areas of improvements and facilitate the revision and approval of Standard Operation Procedures (SOP), Manufacturing Instructions (MI) and other documents
  • Perform risk assessments

Qualifications :

  • 6+ years experience in FDA and / or USDA environment
  • 3+ years experience in validation / qualification
  • Knowledge of US FDA 21 CFR Part 117 and Q7 cGMP requirements
  • Experienced in equipment qualification, method validation, test method development / validation
    • Hace 2 días