Validation Engineer

2 weeks ago


New England, United States EPM Scientific Full time

Title: Validation Engineer


Summary: A leading manufacturing company is looking to add a Validation Engineer to their growing team This is a well-established company with over 50 years of experience in the industry, specializing in manufacturing ingredients used in nutrition products.


The Quality Assurance Supervisor will be 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


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