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Validation Engineer - Fort Wayne, United States - EPM Scientific
Description
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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