Validation Engineer

3 weeks ago


Fort Wayne, 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 Validation Engineer 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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