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
