Description
Mr. Edwin Salazar has over 11 years of experience in medical devices and 20 years of experience in cGMP/GDP environment. Mr. Salazar has been responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment while maintaining areas in high state of inspection preparedness. Experienced in cleaning and equipment validation CIP SIP IQ OQ PQ automation equipment validation skids in an aseptic environment. Validated autoclaves parts washers dryers. Performed cleaning validation developmental runs submitted and executed protocols validated CIP and SIP skids. He has operated production equipment for Cell Culture and Fermentation (Mammalian and Microbial) that includes culture growth process monitoring sampling harvesting freeze thaw and transfer. Mr. Salazar has performed media solution preparation operations and has utilized and complied with cGMP and SOP to maintain records and clean room environment. He has experience in clinical and commercial environments supporting validation activities for biologics facility/operation. Mr. Salazar has executed protocols such as Process Validation computer controlled system validation complex utilities complex manufacturing equipment and basic knowledge of laboratory validation.
Accomplishments
Highlights:
Keywords
- Documentation
- Good Manufacturing Practices
- Manufacturing
- Automation
- Troubleshooting
- Data Backup
- Drafting
- Hazardous Waste
- Instrumentation
- Delta V
- pharmaceutical
- clinical
- phase
- trial
- protocol
- sap
- gcp
- LEAN Manufacturing
- 5 S
- Kanban
- GDP
- CIP/SIP
- Validation
- Automated Controls
- Disposable Bioreactor
- Integrity Testing
- Change Control Management
- IQ/OQ
- BLA
- PAI
- CAPA
- SAFETY
- Clean Room
- Cold Room
- Validation Startup
- Developmental Run
