Jeff Cordero
Lead Validation Engineer IV Upstream/Downstream at AGC Biologics
- Role
- Lead Validation Engineer Iv Upstream Downstream at AGC Biologics
- Location
- Longmont, CO, US
- LinkedIn followers
- 500 followers
Experience
Lead Validation Engineer Iv Upstream Downstream
Dec 2020 — Present · Boulder, CO, US
Manages SIP qualification resources and execution, reports qualification progress to leadership team. Generates reviews and executes equipment and utility protocols. Performs qualification of manufacturing and analytical equipment including media hold studies, media fills and clean utilities to demonstrate equipment meets the expected conditions and design specifications. Develops validation system procedures and methods to ensure compliance and efficiency. Develops risk based strategies for production equipment. Generates, investigates, resolves and closes deviations and associated CAPAs. Responsible for ownership of upstream and downstream systems from a validation perspective and performs impact assessment for change control. Provides technical review of validation data, deliverables and develops final summary reports.
Education
University of Phoenix
Bachelor's Degree, Business-Project Management
2012 — 2014
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