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Lead Validation/verification Engineer Resume

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Center Valley, PA


  • About 7 + years of experience in Healthcare, Pharmaceutical Industry and Enterprise wide applications. having multiple databases with in depth knowledge in 21 CFR, Part 11 Compliance, a strong base in Software Quality Assurance and Computer Related System Validation (CSV).
  • Extensive knowledge in Software Development Life Cycle (SDLC), Validation Life Cycle (VLC).
  • Profound knowledge in systems like LIMS, Clinical Trials, HPLC, GC, SCADA and HPQC .
  • Experience in Validation of application server, backup server and spreadsheets
  • Excellent skills in configuring, validation, manual testing and change controls procedures for LIMS
  • Responsible for writing change control procedures for existing LIMS systems.
  • Efficient in implementing QA auditing and methodologies, test cases, test plans, test documentation and excellent technical skills.
  • Experience in cGxP environments like cGMP, cGAMP, cGLP, and cGCP and developing IQ, OQ, PQ, VMP, VLC, VSD, URS, FRS, TM, VSR and SOPs.
  • Experience and maintenance of electronic records and signatures and their restricted access in accordance to 21 CFR Part 11 annex11 GAP and remediation.
  • Expertise in automated testing tools such as Mercury Quality Center, HP Quality Center and experience in Quick Test Pro (QTP), and Load Runner.
  • Extensive knowledge in Food and Drug Administration (FDA) regulations, 21 CFR, Part 11 (Electronic Records and Electronic Signatures), Part 210 (cGMP in manufacturing, processing, packaging and holding of goods), Part 211 (cGMP for Finished Pharmaceuticals), Part 810 (Medical Device Revise Authority), and Part 820 (Quality System Regulation).
  • Deep understanding of GxPs like GCP, GMP, GAMP and GLP and their proper implementation.
  • Working knowledge of the industry standards like ISO 9000, ISO 9001 and Six Sigma.
  • Specialized skills in Black box (Structural and Functional testing), System & Integration, Regression,
  • Performance, Stress and User Acceptance Testing.
  • Good technical skills in writing Validation Plans (VPs), Test Matrices, IQ, OQ, and PQ protocols, Remedy Plans, FDA Audits and SOPs.
  • Expertise in both manual and automated testing.
  • Dynamic person with drive and perseverance, innovative, creative and enjoys challenges. Positive attitude and desire to complete tasks.
  • Good communication skills along with analytical and problem solving skills.


Clinical Applications: CABS, LIMS, Clinical trials.

Testing Tools: Quality Center, Load runner.

Tracking Tools: TestDirector, Rational Requisite Pro, Rational Clear Quest, Census.

ETL/OLAP Tools: COGNOS, Informatica.

Operating Systems: UNIX, Linux, Windows 95/98/2000/NT/XP, VMS/VAX, MS - DOS

Languages: C, C++, Java, SQL, PL/SQL

Databases: Oracle 10g, SQL Server, DB2, Sybase, MS Access, Crystal Reports, LIMS, MCAS, TOAD

Packages: SAS, MS Office, MS Visio, Developer 2000, VB 6.0, Designer 2000, Developer 2000, Forms 6i, Reports 6i, SQL*LOADER, Rational Rose, Meta Data, Documentum, LIMS

Web technologies: HTML, DHTML, JavaScript, VB Script, Servlets, JSP, ASP, XML, Front Page, Visual InterDev, Application /Web Servers, IBM Web Sphere.

Industry Practices: ISO 9000, ISO 9001, Six Sigma


Confidential, Center Valley, PA

Lead Validation/Verification EngineeR


  • Managed Change Control meeting to ensure FDA requirements were being followed in conjunction with the 21 CFR Part 11 documents annex 11 GAP and remediation. worked with linux, python systems and virutualization (KVM,VMW) Experience with Open stack installation and configuration, testing applications in Openstack environment, in testing REST APIs, DevOps related tools: Jenkins, Puppet, Tempest.
  • Involved in Integration and Functional Testing.
  • Worked on the MS Visio, to draw the workflow diagrams, Process flow diagrams for URS and FRS.
  • Maintained and ensured the accuracy of the requirements in URS and FRS by assigning the critical parameters to each of the user and functional requirements.
  • Create UAT Test Strategy, UAT Test Plans and UAT defect reporting.
  • Facilitate the implementation of a Quality System which complies with ISO 13485, FDA 21 CFR Part 820, and other international regulatory guidelines.
  • Developed the validation protocols for testing plan, design doc worked with linux, python systems and virutualization (KVM,VMW) Experience with Open stack installation and configuration, testing applications in Openstack environment, in testing REST APIs, DevOps related tools: Jenkins, Puppet, Tempest. Experience in TMV - Test Method Validation as a mechanical engineer.
  • Maintained compliance to US FDA, ISO13485, IEC60601, IEC60825, and ISO 14971.
  • Analysis of application requirements and entering of requirements into HP ALM.
  • Tracked and documented Change Requests using HP Quality Center.
  • Responsible for Software and System Verification and Validation activities for Hemodialysis systems.
  • Performed gray box testing (White Box +Black Box testing) and identified different test cases for regression testing.
  • Involved in Computerized system validation (CSV), 21 CFR Part 11 compliance and QMS.
  • Documentation as per FDA standard for all lab equipment and have depth knowledge in HPQC.
  • Managed meetings to review FDA validation protocols and procedures regarding 21 CFR Part 11 Guidance for Industry.
  • Involved in Manual testing.
  • Assist to implementing continuous improvements to the Quality Systems required to execute and implement current good manufacturing practices (cGMPs) related to the manufacturing of finished medical devices.
  • Involved in developing training materials, user manuals, and standard operating procedures.
  • Responsible for Software Development and Lifecycle (SDLC) planning for all aspects of GMP and GLP.
  • Developed Quality Control Systems to ensure proper tracking of documentation in conjunction with FDA requirement.
  • Insure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements.
  • Promoted to handle the development of the Product Development and Product Management (PDPM) for all aspects of the validation process to ensure a quality Traceability Matrix (TM).
  • Managed teams of SOP technical writers, Validation coordinators, FDA advisor board, Change Control Committees and Technical staff.
  • Assessed company’s Quality Control Systems (QCS) and developed a qualification plan for implementation.
  • Involved in Electromechanical medical device assessment and testing perISO14971.
  • Established risk analysis process, defect identification and tracking, validation/verification program.
  • Implemented test automation using tools from HP (QTP and Test Director/Quality Center).

Environment: Windows XP, Quality Center 11, Oracle 10g, QTP, Rational Requisite Pro, SOPs, HP ALM, CSV, 21 CFR Part 11, Load runner, LIMS, Citrix, MS Visio, UAT, VSS and Crystal reports.

Confidential, Bridgewater, NJ

Validation Analyst


  • Responsible for writing Master Validation Test Plan for Caliber LIMS system.
  • Performing validation of Medical Systems medical devices for radiotherapy, radio surgery, proton therapy, and brachy therapy treatments in compliance with FDA QSR design control requirements 21 CFR Part 820.30, 21 CFR Part 11, IEC 62304 Software Life Cycle Processes, ISO 13485 Quality Standard and HIPAA.
  • Designed tests that included functional verification, system performance, regression, boundary, interface and fault insertion testing
  • Used Quality Center as test management tool for storing the automated test scripts from where Scripts can be executed directly by manual testers.
  • Performed black box, module, Functional, integration and system testing.
  • 21 CFR Part 820 and Part 11 FDA Quality System Regulation for medical devices.
  • Involved in computerized system validation (CSV) life cycle documentation required to adhere to regulations concerning computer system validation (CSV) and 21 CFR Part 11 compliance.
  • Involved in MS Access data Validation basing on the time stamp based on the user id and logs.
  • Responsible for writing Test Cases and Test Scripts for sample manager module of LIMS system.
  • Participated in writing Sops, Test Strategy, Summary Reports and Incident Report.
  • Involved in Validating System using cGMP, cGLP Guidelines.
  • Prepared documentation for Validation life cycle, in accordance with 21 CFR Part 11 FDA regulations including Validation plan and Protocol, Installation Qualification (IQ) specification, Operation Qualification (OQ) specification, and performance Qualification (PQ) for LIMS system.
  • Performed Manual Testing for LIMS Sample manager module.
  • Used ALMfor Test management/ Defect Tracking.
  • Involved in maintaining Requirement Traceability Matrix (RTM).
  • Worked on Quality centre to assign and to keep track of the bugs.
  • Maintain training materials and update documents after each product release.
  • Fully involved in UAT testing phase to support client.
  • Preparing FRS (Step by Step technical execution of application features).
  • Imported existing test cases from Excel sheet to QC (Quality Center).
  • Developed, implemented and managed multiple programs and product line
  • Provided design, drawing and specification before releasing.
  • Interact with the end users to understand business requirements & define requirements specifications.

Environment: Windows XP, MS Visio, QTP, HP/Mercury Quality Center 10, HP ALM, UAT, Citrix, SOPs, Rational ClearQuest, CSV, Cognos, Oracle 9i, TOAD, and Caliber LIMS.

Confidential, Silver Spring, MD

Validation/Verification engineer


  • Developed test plan and executed validation protocols for various computerized GMP software and hardware systems for HPLC, UV/VIS Spectroscopy, USP water system, HVAC system, PLC,HPQC,and SCADA.
  • Used HP/Mercury Quality Control (QC) to create and execute test cases/scripts, maintain and track requirements, and Generated standard and customized reports.
  • Involved in both manual and automated testing. Experience in TMV - Test Method Validation (Analytical Method, Attribute Test Method, Compendium Method, Destructive Test Method, Design of Experiment, Gage R&R, Inspection Method, MSA, Non-Destructive Test Method and Variable Test Method).
  • 21 CFR Part 820 and Part 11 FDA Quality System Regulation for medical devices.
  • Completed 21 CFR part 11 Audit/GAP analysis, developed Validation Master plan, Remediation plan, User requirement specifications, Functional requirement specifications, Test Plans, Test Scripts, Test summary report, Data Migration Plan, Traceability Matrix (TM) and Validation summary reports.
  • Worked as validation of mechanical equipment and wrote the Validation Test plan according to IEEE standards, which are in conjunction with FDA regulations.
  • Involved in Validation and Verification.
  • Used Quality Center as test management tool for storing the automated test scripts from where Scripts can be executed directly by manual testers.
  • Co-ordinate for audits from FDA,ISO 1 & ISO14971, CE, MDD, UL, TUV the external agencies & Internal Audit.
  • Revamped existing procedures to comply with QSR/ISO/CMDA standards.
  • Performed GUI testing, Functional testing, Integration testing, Regression testing and Ad -hoc testing.
  • Following FDA Regulations (21 CFR Part 11 and 21 CFR 820) andGAMP 4.
  • Wrote documentation for all aspects of the computer systems validation (CSV) lifecycle, in accordance worked with linux, python systems and virutualization (KVM,VMW) Experience with Openstack installation and configuration, testing applications in Openstack environment, in testing REST APIs, DevOps related tools: Jenkins, Puppet, Tempest. with FDA regulations, particularly 21 CFR Part 11, including: Validation Plan and Protocol, Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification.
  • Involved in computerized systemvalidation(CSV) andGAMP 4guidelines.
  • Performed System validation before the commencement of the Validation process.
  • Tracked the validation progress through Validation Assessment Reports.
  • Involved in validating SOPs with compliance to CFR Part 11, 210, and 211.
  • Maintained all training materials for associate and managerial level training.
  • Stored and executed test data in Quality Center ALM.
  • Performed Black box and White Box testing.
  • Involved in Regulation for software and medical devices.
  • Created ISO/QSR/CAPA training presentation to educate over 100+ personnel.
  • Involved in meetings with users to review and approve Business Process Procedure (BPP), User and Functional Requirement Specifications (URS & FRS).
  • Provided governance for UAT and Unit testing.
  • Baseline the Test Plan, Test Criteria & Project Schedule by walkthroughs and review meetings.

Environment: Windows XP, Quality Center 10.0, QTP 9.0, Oracle 9i, Rational Requisite Pro, HP ALM, SOPs, UAT, Rational Clear Quest, CSV, LIMS, Citrix, Cognos, Empower 2, Documentum, MS Visio.

Confidential, Whippany, NJ

QA Validation engineer


  • Reviewed Validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures & Records) and FDA Regulations in Software Development Life Cycle (SDLC).
  • Interacted with the R&D team in gathering and documenting User Requirements Specifications (URS)
  • Created and reviewed Functional Requirements Specifications (FRS) for LIMS sample module.
  • Created and authored documentation for all aspects of the computer systems validation (CSV) lifecycle in accordance with FDA regulations, particularly 21 CFR part 11, including: Validation Plan and Protocols for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) and Validation Summary report (VSR).
  • Written test cases to test the application manually in Quality Center and automated using Quick Test Pro.
  • Developed and conducted training and awareness on FDA QSR, ISO 13485, ISO 9001, and other medical device regulation.
  • Prepared SOPs, IQ, OQ, and PQ for the installation, operation and performance of Labvantage LIMS.
  • Performed GUI testing, integration testing, regression testing, Functional testing, Ad -hoc testing and negative testing.
  • Implementation and Management of 21 CFR Part 820 Quality Management System, 21 CFR Part 11.
  • Involved in writing the Computer System Validation(CSV) Risk Assessment documents.
  • Updated System Design Specification (SDS) document and validated audit trails for events time stamping requirements.
  • Wrote training materials and SOP’s.
  • Design control process is in compliance with applicable standards and regulations, including FDA QSR, ISO 9001, EN46001 and Medical Device Directive.
  • Created and maintained Requirements Traceability Matrix (RTM) to track user and functional requirements.
  • Stored and executed test data in HP Quality Center ALM.
  • Conducted review sessions on test case and regression test scripts in quality center.
  • Wrote Working Instructions for different users of the application and assisted in drafting the Standar worked with linux, python systems and virutualization (KVM,VMW) Experience with Openstack installation and configuration, testing applications in Openstack environment, in testing REST APIs, DevOps related tools: Jenkins, Puppet, Tempest.
  • Performed Functional and UAT testing before the system went live.

Environment: Windows XP, LIMS, Quality Center 10.0, QTP, Documentum, SOPs, HP ALM, CSV, UAT.


Validation Analyst


  • Designed, implemented and validated 21 CFR Part 11 compliance strategies for LIMS.
  • Played a major role in performing part 11 assessment, especially contributing to the components involved in the maintenance ofElectronic Records (ER), Electronic Signatures (ES) and Audit Trailsin accordance with 21 CFR part 11 regulations.
  • Requirements writing and management, Design Control, SDLC, 21 CFR Part 820 Quality Management System.
  • Analyzed Computer System Validation documents including User Requirements (URS) and Functional Specifications (FS) for DOORS, IAS, and Minitab.
  • Executed the test cases usingHP Quality Center and documented results as part of IQs, OQs and PQs.
  • Used Microsoft Share Point as the version tracking tool for managing the requirements documentation, and Microsoft Project for Project planning and management
  • Wrote and reviewed the procedures pertaining to Installation Qualification (IQ), Operational Qualification (OQ) for the LIMS application.
  • Developed and implemented complete software validation and quality assurance programs including SOPs.
  • Ensured compliance to QSR/ISO regulations/standards by performing facility wide audits including cleaning/passivation.
  • Ensuring that the clinical and medical device documents are in compliance with cGMP and GLP guidelines.
  • Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts.
  • Executed validation test cases based upon system requirement and FDA standards.
  • Worked on change controls and executed changes in production as per the change requests.
  • Create UAT test cases and execution for UAT department.
  • Involved in reviewingCorrective Action and Preventive Action (CAPA)and draftingRemediation plansfor the project management approval after GAP analysis.
  • Involved in writing the Computer System Validation(CSV)Risk Assessment documents, Test Summary Documents andValidation Summary Report (VSR)to summarize overall validation activities.

Environment: Windows XP, CFR Part 11, RTM, SOPs, UAT, HP Quality Center


Validation/Technical Writer


  • Worked on patient monitoring system and generated its Adverse Event report.
  • Worked on AERS to capture all clinical trials.
  • Ensuring that the clinical and medical device documents are in compliance with cGMP and GLP guidelines.
  • Responsible for reviewing and documenting Validation Plan, IQ/OQ/PQ protocols and Validation Summary Report in accordance with Good Documentation Practices(GDP).
  • Developed and analyzed Test Scripts to check the functionalities of the application for 21CFR part 11 compliance
  • Reduced rejects and improved cost savings by conducting over 450 internal/external supplier audits for QSR/ISO compliance.
  • Also performed User Acceptance Testing (UAT), Load testing and Performance Tests for the entire application.
  • Used Test Director to organize and plan all the functional and performance scripts.
  • Responsible for weekly status reports and updates showing the progress of Manual Testing effort and open issues to be resolved.
  • Reviewed Test plan test strategies and test scripts for validation testing.
  • Reported and tracked testing progress in the customized defect tracking system.
  • Developed protocols for audit trail, time stamp and electronic signature for workflow of documents.
  • Verified the accuracy of the database maintained and updated as per feedback from the client.

Environment: Windows XP, AERS, IQ/OQ/PQ, UAT, Documentum, Quality Center

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