Manny Rodriguez
cGMP Consultant specializing in QA & Validation
- Role
- Sr Validation Engineer - Cw at Avexis, Inc
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Manny Rodriguez
Rodriguez Quality Validation Services, LLC (Principal) Solution-oriented professional with over 22 years of technical and management experience in the pharmaceutical, biotechnology, and medical device industries. Proven track record of consistently providing results and accomplishing goals within required timelines. Experience in: Quality Assurance: Change control, NC/CAPA, Audits, SOP/MP, Process Monitoring, Technology Transfer, Product Commercialization, Quality by Design, Program Development, and Risk Management. Validation: Equipment/Utilities Commissioning and Qualification, Cleaning, Process, and Laboratory systems. Regulatory: Filing and Inspection readiness/support.
Experience
Sr Validation Engineer - Cw
Nov 2018 — Present · Research Triangle Park, NC
Work closely with the Global Engineering Director to enhance the CQV program-CQV lead for plant and clean utilities for a new $60M facility-Generated the Validation Plan for the project.
Education
California State University-Los Angeles
B.S., Biochemistry, Microbiology
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