Bharat Mekwan
Sr. Validation Engineer
- Role
- Sr Qa Validation Consultant at Regeneron
- Location
- Rensselaer, NY, US
- LinkedIn followers
- 500 followers
About Bharat Mekwan
Experienced CQV Engineer with a demonstrated history of working in the pharmaceuticals / biopharmaceutical industry. Skilled in CIP, SIP, Good Manufacturing Practice, Good Laboratory Practice (GLP), Biotechnology, Regulatory Requirements, Root Cause Analysis, Process Validation, Temperature Mapping and Equipment Commissioning / Qualification. Strong engineering professional with Master\'s and B.S. focused in Pharmaceutical Sciences.
Experience
Sr Qa Validation Consultant
Nov 2022 — Present · Rensselaer, NY, US
Education
Hemchandracharya North Gujarat University
Bachelor's degree, Pharmaceutical Sciences
2003 — 2007
The University of Findlay
Master's degree
2008 — 2010
Skills
- Deviations
- Fda Gmp
- Process Validation
- Quality Assurance
- Regulatory Requirements
- Regulatory Affairs
- Quality Control
- Gmp
- Calibration
- Six Sigma
- Equipment Qualification
- Validation
- Vendor Audit
- 21 Cfr Part 11
- Technology Transfer
- Hvac
- Documentation
- Kaye Validator
- Glp
- Hplc
- Fmea
- Manufacturing
- Quality System
- V&V
- Ich Guidelines
- Biotechnology
- Microsoft Office
- Engineering
- Pharmaceutical Industry
- Sop
- Fda
- Capa
- Sip
- Biopharmaceuticals
- Chromatography
- Cip
- Root Cause Analysis
- Change Control
- Protocol
- Equipment Commissioning
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