Validation Engineer
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
Validation Engineer
Experienced in equipment qualification, method validation, test method development/validation. Execute Installation/Operational/Process Qualification/Process Validation (IQ, OQ, PQ, PV) protocols. Support the Validation Master Plan and Calibration program activities. ...
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