Yashwanth K.
Experienced Validation Engineer | Pharmaceutical & Biotech | Equipment, Process, CSV & MES Validation | cGMP, FDA Compliance | Risk Assessment & Regulatory Readiness
- Role
- Validation Automation Engineer at Regeneron
- Location
- Albany, NY, US
- LinkedIn followers
- 500 followers
About Yashwanth K.
Validation Engineer with 9+ years of experience in CSV, MES, Automation, and CQV across pharmaceutical and biotech environments. Skilled in IQ/OQ/PQ of equipment, utilities, and cleanroom systems; validating SCADA/DCS (DeltaV, Siemens PCS 7), PLCs, and MES platforms including Rockwell PharmaSuite, Siemens Opcenter/Camstar, and Emerson Syncade. Proven track record ensuring 21 CFR Part 11 compliance, data integrity, and seamless automation integration to support audit readiness and operational excellence.
Experience
Validation Automation Engineer
Apr 2024 — Present · NY, US
Developed and executed CSV deliverables (URS, RTMs, risk assessments, test scripts, and summary reports) for automation systems including Siemens PCS 7 (Batch, Historian) and DeltaV.Configured and validated DeltaV automation logic and HMI applications for process and utility equipment, ensuring compliance with 21 CFR Part 11, Annex 11, and GAMP 5.Authored and maintained validation master plans and data integrity reports to support GMP readiness and ongoing audit compliance.
Education
Visvesvaraya Technological University
Bachelor of Engineering - BE
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.