Edwin Luquis
CSV, CQV, QAV
- Role
- Cqv Validation Engineer at 博士伦
- Location
- Atlanta, GA, US
- LinkedIn followers
- 500 followers
About Edwin Luquis
Biotechnology professional whit 5 years of experience in the regulated industry:…
Experience
Cqv Validation Engineer
Feb 2025 — Present · Greenville, SC, US
CQV Specialist – IHP Sterilization System for Aseptic Filling LineExperienced in Commissioning, Qualification, and Validation of Ionized Hydrogen Peroxide (IHP) sterilization systems within aseptic filling environments. Led the development and execution of PQ protocols, including biological and chemical indicator validations. Ensured compliance with FDA, EU GMP Annex 1, and ISO standards for surface and enclosure decontamination. Collaborated closely with engineering, QA, and vendors to ensure sterility assurance and equipment readiness.
Education
Nova Southeastern University
Master of Business Administration - MBA, Process improvement
2017 — 2018
Instituto Tecnologico de Puerto Rico- Recinto de Manati
Associate's Degree, Electromechanical Instrumentation and Maintenance Technologies/Technicians
2005 — 2008
Nova Southeastern University
Master of Business Administration - MBA, Process Improvement
2017
Universidad del Turabo
Associate's Degree, Biotechnology
2008 — 2010
Universidad del Turabo
Bachelor's Degree, Biotechnology
2010 — 2013
Skills
- R&D
- Capa
- Pharmaceutics
- Pharmaceutical Sales
- Sales Effectiveness
- Laboratory
- Regulatory Affairs
- Quality System
- Clinical Trials
- Calibration
- Biotechnology
- Pharmaceutical Industry
- Sop
- Fda
- Cross-Functional Team Leadership
- Hplc
- Clinical Development
- Validation
- Quality Control
- Gmp
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