Rohith K

About Rohith K

I am a Senior CQ & Validation Engineer with over 7 years of specialized experience in the pharmaceutical and life sciences industry, driving the commissioning, qualification, and validation (CQV) of complex facilities, utilities, and process equipment. My expertise lies in high-stakes, regulated environments where I implement risk-based validation strategies and rigorous Computer System Validation (CSV) to ensure full alignment with FDA 21 CFR Part 11, GAMP 5, and cGMP standards.Throughout my career, I have spearheaded 30+ CQV projects for industry leaders like Merck and Alcon, managing $10M+ capital portfolios with a focus on audit-readiness and technical excellence. I am particularly passionate about digital transformation in validation, utilizing Kneat Gx and Lean Six Sigma methodologies to eliminate documentation errors and significantly accelerate project lifecycles.Key Leadership & Technical Achievements: Process Optimization: Reduced validation cycle times by 15% and documentation errors by 25% through the strategic implementation of digital validation workflows. Regulatory Success: Maintained a record of zero critical deviations and supported FDA audit-readiness with zero 483 observations across multi-million dollar capital projects. Technical Mastery: Led end-to-end qualification for critical systems, including autoclave cycle development, clean steam generators, isolator systems, and HVAC infrastructure. Specialized Studies: Authored and executed advanced protocols for Light Mapping and Airflow Visualization (AVS), ensuring 100% compliance with ISPE and Annex 1 regulatory standards for aseptic manufacturing.Core Competencies:IQ/OQ/PQ Lifecycle | CSV & Data Integrity | ASTM E2500 Risk-Based Approach | Kneat Gx Digital Validation | SOP & Technical Report Writing | Environmental Monitoring | Project Management (PMP Candidate)| CAPA & Deviation Management | GAMP 5 | FDA

Experience

1. Senior Validation Engineer

   Merck

   Mar 2026 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Strategic Project Management: Direct the end-to-end Commissioning, Qualification, and Validation (CQV) strategy for $10M+ capital projects, including DS4 and VMF initiatives, ensuring zero critical deviations.• Digital Validation Leadership: Act as a Subject Matter Expert (SME) for Kneat Gx, spearheading the transition from paper-based to digital validation workflows to improve efficiency by 25%.• Risk-Based Methodology: Implement advanced ASTM E2500 verification approaches to streamline the qualification of complex systems like Skan Isolators and depyrogenation tunnels. • Compliance Oversight: Oversee the full CSV lifecycle for Building Automation Systems (BAS) and environmental monitoring, maintaining strict alignment with GAMP 5 and FDA 21 CFR Part 11.• Cross-Functional Investigations: Lead root cause analysis (RCA) for complex deviations, utilizing Ishikawa and FMEA methodologies to drive CAPA closures and maintain audit-ready status.

Education

• Narayana junior college

  Intermediate, Maths physics chemistry

  2012 — 2014

• Tejaswi High School

  SSC

  2012

• Jawaharlal Nehru Technological University, Hyderabad

  Bachelor of Technology - BTech, Aeronautical/Aerospace Engineering Technology/Technician

  2014 — 2018

• University of Central Missouri

  Masters, Engineering/Industrial Management

  2019 — 2020