Sean Abel
Seasoned Life Sciences Engineering professional with over 20 years experience in process development, process validations, equipment qualifications and manufacturing engineering support.
- Role
- Staff Validation Engineer at Vivex Biologics
- Location
- Hollywood, FL, US
- LinkedIn followers
- 500 followers
Information TechnologyView LinkedIn profile
Experience
Staff Validation Engineer
Jan 2024 — Present · Miami, FL, US
Education
University of Miami
Bachelors of Science, Biomedical Engineering
1991 — 1997
Florida International University
Masters of Science, Engineering Management
1999 — 2001
Knox College
High School Diploma
1982 — 1987
Skills
- Spc
- Product Development
- Fmea
- Value Stream Mapping
- Minitab
- Failure Mode and Effects Analysis (Fmea)
- Biomedical Engineering
- Commercialization
- Failure Analysis
- Cross-Functional Team Leadership
- Supplier Quality
- Iso 14971
- Quality Control
- Gmp
- R&D
- Root Cause Analysis
- Iso
- Fda
- Continuous Improvement
- 21 Cfr
- Corrective and Preventive Action (Capa)
- Gd&T
- Ce Marking
- Medical Devices
- Capa
- Kaizen
- Validation
- Design Control
- Dmaic
- Manufacturing Engineering
- Quality System
- V&V
- Process Simulation
- Six Sigma
- Product Launch
- Tolerance Analysis
- Process Capability
- Manufacturing Operations
- 5s
- U.s. Food and Drug Administration (Fda)
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