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Sep 2005Aug 2007

Master's of Science

Wright State University
  • Basic Imaging techniques (MATLAB coding) such as Image Enhancement, Edge Detection, Image Contrast, Filtering and others
  • Nuclear Magnetic Resonance
  • Computed Tomography
  • Quality Improvement (Six Sigma, Lean Manufacturing)
  • Human Factors Engineering & Ergonomics

Bachelors in Engineering

University of Mumbai, India
  • Process Systems Engineering
  • Instrumentation Systems Engineering
  • Control Process variables
  • Basic instruments for measurement and control

Work experience

Feb 2008Present

Biomedical Engineer- Validation

Software Catalysts, LLC

 Project: Process and Instrument Validation.May 2008- August 2008

As working for this group, I had an opportunity to work for companies from medical device and pharmaceutical industry. I was involved in the development and validation of process and instruments with respect to the regulations. 

Sep 2008Present

Biomedical Engineer - CSV Consultant

Cordis, A Johnson & Johnson Company

Project: Labware Laboratory Information Management System (LIMS)

  • Collected system requirements from various business departments (manufacturing, QC)
  • Developed validation plan, user requirements, specifications and qualification
  • Conducted risk assessment & gap analysis
  • Mapped system test scripts to requirements using Traceability Matrix (TM)
  • Performed testing using automated tools
  • Reported changes to design through change management system
Mar 2010Present

Millennium, The Takeda Oncology Company

  • Manage & promote CSV program for delivery of high quality, compliant Informatics & Visualization
  • Leader and SPOC for CSV QMS and continuous improvements initiatives for conceptualization, consistency, reduce documentation and defect reduction
  • Stakeholder/Owner of various validation policies, procedures, trainings and templates to promote compliance, team productivity, project management and efficiency
  • Inspection Readiness leader for Regulatory and internal audits
  • CSV Knowledge Base owner to reduce variability, increase quality and team built
  • Quality Assurance of Computerized Systems, Software & IT Infrastructure
  • Lead for Change controls, validation, maintenance procedures, deviations, investigations & CAPA
May 2009Feb 2010

Lead Validation Engineer- Consultant

Genzyme Corp

Project: Serialization

  • Authored Mastered Validation Plan (MVP) MFG/PRO ERP system
  • Facilitated review board committee to agreement on CSV deliverables
  • Lead responsibility for creation, execution and mastering qualification protocols and TM.
  • Updated the project team on validation effort
  • Managed discrepancies and deviations and developed Trace Matrix
Jun 2007Aug 2007

Research Test Engineer

Wright State University-WPFAB

Department of Biomedical Engineering; Wright State University, Dayton, OH (in collaboration with Air Force Research Laboratory, Biomechanics Branch, Wright-Patterson Air Force Base). Research was based on design, procedures and requirements for Micro-Compression Sock Study

Jul 2004Jul 2005

Instrumentation and Validation Engineer

Samsons' Royal Cushion Vinyl Products Ltd


  • Ensured continuous operation of vinyl flooring production lines.
  • Collected and analyzed pressure and temperature data of heating and cooling systems.
  • Conducted maintenance of valves, boilers and pneumatic and hydraulic systems.
Jan 2003Jun 2004

Systems Engineer/ Instrumentation Engineer

Zandu Pharmaceuticals Ltd

Zandu Pharmaceuticals Ltd is the leading ayurvedic company in the world. As a Systems Engineer, I was involved in the validation of HPLC systems.


  • Final year undergraduate project on instrumentation and working of HPLC.
  • Tracked samples and obtained information using HPLC, pH meters and balances.
  • Conducted meetings and assisted in the various analysis with the help of HPLC.
  • Studied general structure and working of HPLC.

Image Processing

Validation and Software Testing

Key Words

  • Validation Protocols
  • 21 CFR Part 11
  • 21 CFR Part 820
  • Six Sigma
  • Lean Manufacturing
  • Medical Imaging
  • C , C++
  • Software Testing
  • ISO 13485
  • ISO 9001
  • HL7
  • QTP
  • QC
  • WinRunner
  • Labware LIMS
  • Ergonomics
  • HPLC


  • URS
  • VMP
  • SRS
  • TSD
  • RA
  • IQ
  • OQ
  • PQ
  • SOP's
  • CAPA


Diverse work experience in separate roles as Lead Validation Engineer & Quality Assurance of Computerized Systems

I am committed to Patient Safety, Regulatory compliance, Quality standards and Business goals

oLeadership and development of CSV program

oQMS application to Informatics and Visualization

oSolving problems related to compliance

oEffective Team-Player, preaching quality culture

oPractice and implement Risk Based Approach

oCommitted to Continuous Improvement

oProficient as an Auditee and regulatory inspection

oModerately proficient internal and vendor audits

oEffective Communication skills


  • Change Controls, Validation Plans, Risk Assessment, Requirements, Specifications, Testing, Qualification (IQ/OQ/PQ), Control mechanisms and Reporting
  • Electronic Records and Electronic Signatures (ERES), 21 CFR Part 11, Annex 11
  • Industry guides such as GAMP5, PIC/S, FDA’s Guidance to Software Validation and others
  • SDLC methodologies and Risk-based validation approach
  • IT Infrastructure Qualification, Computerized and Lab System Validation
  • QMS programs: Policies, Procedures, Guidelines, Templates and Training
  • BIMO, Deviations, Investigations, Root Cause Analysis and CAPA’s
  • Understanding of ITIL/ITSM: Incident, Change, Problem and Configuration Management
  • GAMP 5, PIC/S, FDA Guidance to software Validation
  • Fundamentals of Predicate Rules( 21 CFRs Part 820/210/211/58/312/201/801, ISO14971, ISO 13485