Ashwin K
Sr. Manager - Automation, CSV, CQV | Bachelor of Engineering (B.Eng.)
- Role
- Senior Manager at IncepBio
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Ashwin K
Electronics & Instrumentation Engineer specializing in CQV, CSV, and Industrial…
Experience
Senior Manager
Jun 2025 — Present · Bengaluru, IN
Lead Commissioning, Qualification & Validation (CQV) activities from URS to PQ.Execute Computer System Validation (CSV) in compliance with GAMP 5, 21 CFR Part 11, EU Annex 11.Develop and review URS, FS, HDS, SDS, IQ, OQ, PQ protocols and reports.Conduct FAT/SAT for process equipment, utilities, and automation systems.Integrate and validate PLC, SCADA, DCS, BMS, EMS with compliant data integrity controls.Perform risk-based validation and quality risk assessments per ICH Q9.Ensure documentation and systems are audit-ready for regulatory inspections.Collaborate with cross-functional teams to optimize timelines without compromising compliance.
Education
Birla Institute Of Technology and Science, Pilani Dubai
Bachelor of Engineering (B.Eng.), Instrumentation
2005 — 2009
Skills
- Instrumentation
- Telecommunications
- Process Control
- Microsoft Office
- Labview
- Autocad
- Automation
- Engineering
- Programming
- Allen Bradley
- Plc
- Scada
- Project Engineering
- Commissioning
- Testing
- Siemens Plc,Hmi and Scada Programming
- Wonderware
- Plc Programming
- Troubleshooting
- Calibration
- Programmable Logic Controller (Plc)
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