SUMMARY

• Senior Validation Engineer with experience in Medical Device & Pharmaceutical Environment with expertise in Computer System Validation (CSV) and Quality Assurance, Testing, Verification, Technical Documentation (IQ/OQ/PQ) in Compliance to FDA 21 CFR and GxP regulations
• Experience with validation of different types of system such as Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), Electronic Document Management System (EDMS) and Manufacturing Execution Systems (MES)
• Experience in creating, reviewing, editingValidationPlan, Requirements Specification, Test Protocols, Manual Test Scripts, Test Cases and Summary Report of developing/supportingcomputer systemfor a regulated environment. In depth knowledge of Manual Testing and test scripts executions
• Strong working knowledge of Software/Hardware testing (Unit, Integration, Functional, End to End, System, Stress, Performance, andValidationTesting)
• Experienced on 21 CFR part 11 and Audit trial validation process
• Experience in regulatory requirements regarding Computer System Validation(CSV) procedures
• Review current GMP documents for compliance to company SOPs, quality systems and regulatory requirements
• Quality engineering experience with CAPA, Control Plans, and corrective action activities
• Deep understanding in writing Test Plans, Test Cases, Test Scripts and Test Procedures
• Experience in reviewing and modifying User Requirements Specification (URS) and Functional Requirements Specification (FRS)
• Expertise in reviewing and preparing Requirement Documents, Test Scripts and Test Cases as well as allValidationDeliverables.
• Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the noncompliance.
• Experienced with most popular applications like Microsoft Office (MS Project, MS Word, MS Excel, and MS PowerPoint)
• Thorough knowledge of Change Control Management Activities, Back - up and Structured Change Control Procedures
• Quick learner and ability to adapt to changing priorities
• Excellent team player as well as independent worker
• Good communication skills, ability to learn in fast paced environment
• Excellent analytical and problem solving skills with ability to understand and analyze complex issues

PROFESSIONAL EXPERIENCE

Confidential, Queensbury, NY

Sr. Validation Engineer

Responsibilities:

• Generated and reviewed standards of validation deliverables, documented those deliverables in compliance with 21CFR Part11, with the help of the team for Laboratory Information Management System (LIMS) from LabWare
• Developed IQ and OQ protocols as per user requirement, functional requirement specifications and Design specification (URS, FRS and DS) for the LIMS application
• Met with clients and collected information required in order to set the minimum standards of the document
• Involved in reviewing and executing PQ test scripts
• Scheduled and conducted interviews in order to check the document requirements are met for that particular application
• Reviewed/Modified User Functional Requirements Specifications (UFRS)
• Revised Standard Operating Procedures (SOPs) to govern the development, change management, testing, release, deployment, training, document control in its Software Development Life Cycle (SDLC)
• Developed training manuals for operating, auditing, and monitoring functions of the management system
• Created flow charts in MS Visio, assisted with Project Schedules and Task Lists
• Involved in creating and maintaining Requirement Traceability Matrix (RTM) for the application
• Developed test plans, test strategies, test scripts forvalidationtesting using test management tool
• WroteValidationSummary Report to establish documented evidence that the system was validated
• Involved in System Testing with testing team using QTP
• Performed User Acceptance Testing (UAT) for the application

Confidential, Palo Alto, CA

Quality Engineer

Responsibilities:

• Prepared documentation for all aspects of the Computer Systems Validation(CSV) lifecycle, in accordance with FDA regulations including 21 CFR Part 11
• Followed the SOPs of the company for documenting Validation Plan, Test Cases and Test Scripts based on Business Requirements
• Participated in collecting user and functional requirements
• Authored documents independently such as Validation Master Plan (VMP), Function and User Requirements Document, Test Plan, Test Scripts, Test Summary
• Drafted, prepared and documented software Validation protocols (IQ, OQ, PQ)
• Performed Computer System Validation using cGXP guidelines, like mandating GMP, GCP and GLP
• Performed the complete Qualification Package including IQ, OQ, PQ and carried out Platform Qualification and development to new system and software for different laboratory instruments
• Executed test cases and documented results as part of IQs, OQs and PQs
• Monitored the testing and documented theValidationSummary Report
• Performed GAP Analysis and developed Remediation Plan for compliance with FDA regulations
• Maintained Requirements Traceability Matrix (RTM) to track requirements
• Responsible for the management of Deviation Handling documents
• Developed the Test Scripts to generate the Audit Trail reports to verify the creation, modifications to the records are captured in audit trail table logs
• Conducted Functionality testing and Interface testing during the Operational Qualification
• Performed the Back-End integration testing to ensure data consistency on front-end
• Reported to the developers about updates and change defects in the execution of the test scripts and test cases using Quality Center
• Documented theValidationSummary Report (VSR)

Confidential, Indianapolis, IN

Validation Engineer

Responsibilities:

• As a member of Computer Systems Validation team, responsible for documenting and reviewing all thevalidationdeliverables as part ofvalidationpackage
• Involved in the Global Implementation and Validation of Global IT applications, CAPA, CCM Workflows
• Reviewed and updated end to end validation documentation for Track wise (CAPA, CCM) to ensure compliance with company policies and procedures
• Performed regulatory and risk assessment of the computer systems
• Authored VMP (Validation Master Plan) with risk based approach forvalidation, leveraging documented risk assessments
• Responsibilities includes system qualification, assist in the design, analysis and approval of IQ, OQ, and PQ protocol scripts
• Responsible to get QA approval forvalidationdeliverables and Vendor Audit
• Designed, developed and implemented Test Plans using the detailed business requirements document
• Understood data mappings and Created Test Cases and procedures
• Communicatedvalidationapproach and requirements to team and business owner
• Maintained the Traceability Matrix between Requirements, Test cases and Defects
• Extensively involved in Defect tracking, reviewing and analyzing and reporting test result using Quality Center
• Executed the test cases stored in the Test Plan, imported locally to the Test Lab in QC and reported the defects
• Developed OQ and PQ test cases for Trackwise
• Drafted IQ test cases for verifying configuration of Trackwise workflows
• Performed change control by assessing proposed changes to validated processes and identify the validationrequirements necessary to maintain thevalidationstatus after execution of the change

Confidential, Cambridge, MA

Validation Engineer

Responsibilities:

• Involved in developing Requirement Specification Document, System Requirement Specification, and Design Specification
• Validated analytical laboratory equipment such as GC, HPLC, Autoclaves and Incubators in compliance with FDA regulations
• Involved in validating computer system interface with laboratory equipment such as Spectrophotometer, HPLC, GC and Autoclave
• Worked on developing/writing aValidationPlan, SOP's and Work Instructions
• Authored and executed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) scripts
• Validated the Change control Forms for QA and Production moves and ensured the overall risks of all the transports met the Business Criticality
• Participated in meetings with technical writers and project team members to point out deficiencies in requirements and ways to enhance them
• Initiated Good Documentation practice guidelines and workflow diagrams for performing Change Control Management
• Verified the defect reports, Test problem reports/Incident reports, Production problem reports and Scope Change requests during thevalidation
• Gathered Traceability Matrix and performed Gap Analysis in order to meet the User Business Requirements and identified Risk Assessment for all the requirements
• Worked both independently and cooperatively with other team members to meet deadlines

Confidential

Validation Associate

Responsibilities:

• Worked on AERS to capture all clinical trials
• Implemented Track wise in conjunction with 21 CFR Part 11
• Involved in generation of crystal reports and development of crystal reports
• Involved in internal mock audit by quality organization
• Responsible for generating and reviewingCSVdeliverables in compliance with 21CFR Part 11 and GxP FDA Compliance Regulations
• Documented the Vendor Assessment Report
• Developed Design Specifications (DS) document. Used MS Visio for pictorial representation of the Design Specifications
• Responsible for writing training manual and SOPs
• Sharing knowledge for promoting best practices to be followed by project teams
• Responsible for documenting IQ/OQ/PQ protocols
• Created Requirements Traceability Matrix (RTM) to track the User and Functional Requirements
• Developed test plans and test scripts forvalidationtesting
• Responsible for developing protocols for audit trail, time stamp and electronic signature for workflow of documents
• Developed the Validation Summary Report