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Computer System Validation /quality Engineer Resume

Montville, NJ


  • Diverse experience as a Validation Engineer/ Quality Analyst with focus on Computer system Validations, cleaning validation, Process validation and Equipment validation in Pharmaceutical and Medical device industry with emphasis on GAMP, cGxP & FDA regulations.
  • Strong background in Commissioning, Qualification, Validations and Quality. Knowledge in FDA, GMP's, GAMP5, GxP, CSV, MES, ERP, Lab equipment, PLC and Kaye Validator
  • Experience in performing DOE's (feasibility runs) for Manual cleaning, CIP, SIP and COP systems in order to develop necessary parameters and cycles.
  • Strong on experience in using analytical lab instruments such as GC/MS, LCMS, MALDI Imaging & a wide spectrum of other HPLC, UV/Vis, Ph Meters, Autoclaves, incubators, chambers, Freezers, Oscilloscope.
  • Extensive knowledge and experience in validating computer systems following Software Development Life Cycle (SDLC) as per FDA regulations and cGXP (GLP/GCP/GMP) guidelines.
  • Strong expertise in FDA regulations, GxP suites (GAMP4 & GAMP5, GDP), Computer System (CSV) & Equipment Validation, Documentum, LIMS, AERS, CTMS and TrackWise.
  • Strong knowledge and experience in developing Validation Mater Plan (VMP), Requirements (URS/FRS), Qualification Documents (IQ, OQ & PQ), Validation Summary Report (VSR) and Requirements Traceability Matrix (RTM).
  • Experience in authoring and reviewing Qualification documents (IQ, OQ & PQ), Standard Operating Procedures (SOPs) to be compliant as per FDA Regulations.
  • Experience in writing protocols, executing test scripts and constructing Summary Reports for IQ, OQ and PQ.
  • Experience in Data Migration, Periodic Review, Change Controls, Change Reporting, GAP Analysis, and Risk analysis, CAPA, FMEA and Remediation Process.
  • Good knowledge on GMP/QSR/FDA regulations including 21 CFR Part 11, 210, 211, 820, IS0 13485 & 14971.
  • Oversees qualification of laboratory equipment, including IQ/OQ/PQ and Calibration/Maintenance programs.
  • Specialize in developing and implementing appropriate standard operating procedures (SOP), Standard working Practices (SWP), Operation and Administration Manuals
  • Proficient in manual and automated testing tools and to perform integration testing, user acceptance testing, black box testing, functional testing, load/performance testing, security testing, back - end and regression testing
  • Proficiency in Defect Management, including Defect creation, modification, tracking, and reporting using Industry standard Tools like HP Quality Center
  • Well versed with MS Office. Excellent oral & written communication skills. Expert in Technical writing.


Computer System Validation /Quality Engineer

Confidential - Montville, NJ


  • Reviewed, analyzed and approved test scripts through automated HPQC for ERP in Sales and Distribution module, instrument systems such as GC, LC, FTIRs, and Mass Spectrometers
  • Conducted system regression and performance automated testing for LIMS and Waters systems applications
  • Validated TrackWise module for CAPA and Electronic Signatures per FDA code 21 CFR Part 11
  • Effectively used Documentum for creating and retrieving CSV documentation such as Validation Plan, Test Plans, Test Summary Reports, Requirements Trace Matrix, and Validation Summary Report
  • Prepared and provided change controls to Change Authorization Board (CAB) on supporting applications
  • Performed manual and automated testing using HPQC.
  • Experienced with Waterfall, Agile and RUP methodologies
  • Involved in Performance testing, Regression testing, and SQL Server BI Testing
  • Authored Standard Operating Procedures (SOPs) and User Manuals based on vendor provided documentation
  • Effectively ensured GMP requirements for data archiving, change control, disaster recovery are met for GMP operations
  • Performed quality review of instrument Installation Qualification / Operational Qualification / Performance qualification documentation

Validation Engineer / Quality Analyst

Confidential - Hauppauge, NY


  • Reviewed Business Requirements and prepared Validation Master Plan to implementSQL LIMS.
  • Configured the system according to user requirements.
  • Documented all aspects of Computer System Validation in accordance with cGMP, cGLP and cGCP guidelines and 21 CFR Part 11.
  • Assessed the risk involved in adding modules
  • Involved in documentation and execution of Installation Qualifications, Operational Qualifications, and Performance Qualifications.
  • Performed Manual Testing for Front - End Functionalities and Back-End Operations.
  • Used SQL Queries for backend testing.
  • AnalyzedTest Scripts to ensures compliance with 21 CFR parts 11 with respect toAudit Trail, Data Integrity and Data Security of the application.

Validation Engineer/ QA

Confidential - Fort Worth, TX


  • As a (CSV) Engineer, was involved in gathering and validating new Labeling Application systems
  • Developed Validation Master Plan (VMP) in accordance with FDA compliance standards
  • Followed Computer Systems Validation (CSV) Master Plan to author, review and approve CSV deliverables for systems as per GxP (GLP, GCP, GMP) FDA Assessment
  • Equipment validation and Technical documentation as per FDA/ISO 13485 and GAMP regulations
  • Developed IQ/OQ/PQ and MSA protocols by identifying inspection and test activities.
  • Preparing compliance report about existing status of the cGMP, GCP and GLP
  • Implemented and validated 21 CFR Part 11 compliance strategies for LIMS
  • Reviewing Validation deliverables Validation Master Plan (VMP), Validation Summary Documents (VSD), Validation Summary Reports (VSR), Installation Qualification/ Operational Qualification/ Performance Qualification, and Requirements Traceability Matrix
  • Reviewed validation (IQ/OQ/PQ/PPQ/TMV) and provided technical input to ensure validation reports were qualified to company and regulatory requirement
  • Analyzed test scripts to be compliant with 21CFR Part 11 regulations, maintaining validation records and following relevant SOPs
  • Compliance related to Electronic Signatures and Electronic Records for Trackwise System Data Migration, Periodic Review, Change Controls, and Change Reporting, GAP Analysis, and Risk analysis, CAPA, FMEA and Remediation Process

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