SUMMARY

• Validation Engineer with about 6 plus years of experience in pharmaceutical and biomedical industries with roles of increasing responsibility, including but not limited to commissioning, qualification, and validation of computer systems along with technical documentation.
• Experience in Validation of Computer applications such as Documentum, LIMS, and CMMS applications, in compliance with FDA regulations and GLP, GMP, GCP guidelines.
• Expertise in conducting Risk Assessment, 21 CFR Part 11 Assessment, Security Assessment, and documenting as per GAMP 5 guidelines.
• Thorough experience in using Six Sigma tools - FMEA, Root Cause Analysis, and Statistical Process Control (SPC).
• Experience in documenting User Requirements Specifications (URS) and Functional Requirement Specifications (FRS) documents.
• Experience in developing Test Plan, Test Cases. Experience in authoring, executing, and reviewing Test Scripts.
• Experience in preparing and documenting Validation Summary Reports (VSR) and Validation Master Plan (VMP).
• Experience in developing and executing validation strategy and validation schedule ensuring agreement with key stakeholders.
• Excellent Experience in working in testing tools like QTP and other Testing Methodologies.
• Experience in testing through thorough understanding and knowledge of various phases of the System Development Life Cycle (SDLC) approaches (prospective and retrospective).
• In-depth knowledge in FDA 21 CFR Parts 11, 210, 211, 50, 56, 58, Electronic records, Electronic signatures, and Audit Trails.
• Experience in validation of Laboratory Information Management System (LIMS).
• Advanced experience in generating Requirements Traceability Matrices (RTM), conducting GAP Analysis and documenting Remediation Plans.
• Well versed in reviewing and approval of Corrective Action and Preventive Action (CAPA), laboratory investigations, protocols, forms, and instructions to ensure compliance with cGMP and regulatory filings.
• Excellent oral and written communication skills, strong interpersonal skills, and strong team work spirit with excellent leadership qualities.

TECHNICAL SKILLS

FDA Regulations/ Validation Protocols: 21 CFR Parts 11, 210, 211,50, 56, 58, cGXP (cGMP, cGLP, cGCP), FDA, ISO, EU, and ICH guidelines, Validation, IQ, OQ, PQ, VMP, VSR, Testing, Remediation Plans, RTM, Gap analysis

Applications, Testing and Tracking Tools: LIMS, QTP, HP Quality Center, Documentum

SDLC: Agile, Waterfall, and V model

Analytical Software: Chemstation, LIMS, AERS

Business Tools: MS Office (Word, Excel, Power Point, Visio)

PROFESSIONAL EXPERIENCE

Confidential, North Chicago, IL

Validation Tester/ Analyst

Responsibilities:

• Wrote system requirements and Verification/Validation (V&V) test cases.
• Developed Test Plan and Test Cases for performing User Acceptance Testing (UAT).
• Authored, executed, provided guidance, and reviewed validation Test Scripts according to the requirement specifications including positive, negative, and challenge testing.
• Documented test results and ensured the test results are in accordance with standards.
• Generated reports and routed documents for approval.
• Developed and executed validation strategy and validation schedule ensuring agreement with key stakeholders.
• Supported validation efforts and deliverables for projects requiring validation.
• Prepared Requirement Traceability Matrix (RTM) to track requirements and correlate with conducted test cases using Quality center.
• PerformedGAP Analysisto identify GAPs in the Risk assessment and prepared remediation plans to fix them.
• Involved in updating Functional Requirements document based on approved User requirements specifications.
• Maintained Change Control documentation in accordance with SOPs, Conformance standards and company methodology.
• Involved in creating Incident Reports, routing and tracking, finalizing and closing.
• Closely worked with Subject Matter Experts (SME's) and Computer System's Owners (CSO) for gathering the requirements.

Confidential, Ann Arbor, MI

Validation Engineer

Responsibilities:

• Tested the LIMS application and developed Test Cases for LIMS.
• Worked with users and LIMS team to interface LIMS to various lab systems. Performed data verification and privilege checks for the ADMIN LIMS application.
• Involved in preparing and documenting Validation Summary Reports (VSR) and Validation Master Plan (VMP).
• Developed Remediation Plan to bring the system in compliance with GxP (GMP, GCP, and GLP).
• Experience documentation of user requirements and functional design specifications.
• Prepared User Acceptance Test Plans, Test Summary Report and Traceability Matrices in accordance with the Company's change management policy.
• Involved in writing Test Cases based on Functional Requirements and design documents.
• Performed 21 CFR Part 11 Validations under PDMA regulations for the drug sample management module within the Sales force automation application.
• Reviewed validation plan for LIMS and authored Validation Plan (VP) for upgrade of LIMS to GAIMS.
• Customized and validated different components of the LIMS modules.
• Created & Tested Files for Import/Export testing using Informatica ETL tool.
• Developed and maintained SQL Scripts, test whether Data Integrity and Referential Integrity were being met.
• Performed Regression testing against each new build.

Confidential, Kalamazoo, MI

Validation Engineer

Responsibilities:

• Involved in designing and developing Extraction, Transformation and Load (ETL) processes and also performed some transformations using SQL Server Integration Services (SSIS).
• The project involved execution and documentation of validation data, protocols, reports, SOPs, risk assessment and document changes. It also involved review of IQ/OQ/PQ protocols, final reports, and equipment and quality standards, as related to GMP equipment/facilities/utilities.
• Validated the process in accordance with the FDA rules and regulations and managed software upgrades, enhancements, and maintenance in a compliance with cGMP environment.
• Involved in risk assessment and gap analysis with upgrade implementation.
• Generated Requirement Traceability Matrices (RTM) by tracking requirements that are co-related with the conducted test cases.
• Routed all the validation deliverables using Electronic note book (ELN)
• Prepared RTM to track requirements and correlate with conducted test cases using Quality center.
• PerformedGAP Analysisto identify GAPs in the Risk assessment and prepared remediation plans to fix them.
• Involved inUser Acceptance Testing (UAT)to verify that all the user requirements are met and interact with team members and stake holders.

Confidential, Frederick, MD

Validation Engineer

Responsibilities:

• A member of the assessment team to review the 21 CFR Part 11 requirements
• Develop and execute validation guidelines for GMP, GCP and GLP.
• Drafted new SOPs for the LIMS and trained personnel on the systems.
• Supported a parallel project of LIMS and in the transition of HPLC and FTIR spectrophotometer systems.
• Prepared and developed software validation protocols for integration of LIMS.
• Performed Gap Analysis to obtain sufficient information for LIMS (Requirements, H/W, S/W, SOPS, 21 CFR 11 Criteria and new interfaces, if any).
• Wrote, reviewed and approvedapplicable policies, test execution reports, validation review reports, change control forms, standard operating procedures (SOPs), work practices (WPs), IQ’s, OQ’s and PQ’s, guidelines specific to change management, deliverables for change control of LIMS.
• Involved in analyzing the business requirements to develop Validation Master Plans (VMP), Test Plan, Test Cases and Test Scripts.
• Implemented Computer Software Validation and quality assurance programs including Standard Operating Procedure (SOPs) of validation protocols.
• Major validation activities included documentation & validation of Validation Protocol and plans, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
• Validated Standard Operating Procedures to ensure compliance with FDA regulations namely 21 CFR Part 11.
• Involved in performing GAP analysis of the current system and create Remediation Plan for potential risks and failures for process and product.
• Worked with Requirement Traceability Matrix (RTM) to track requirements to co-relate with the conducted test cases.

Confidential - Cambridge, MA

Validation Engineer

Responsibilities:

• Analyzed and assisted in the documentation of business requirements and developed Validation Master Plan.
• Created flow charts using MS Visio to understand the flow of application and overview of the software system to be validated.
• Experience writing systems requirements and Verification/Validation (V&V) test cases for medical devices
• Developed Test Plan and Test Cases, wrote Test Scripts.
• Generated reports and routed documents for approval.
• Reviewed SDLC/Validation deliverables like Design Specifications, System Use, and System Admin Operating Procedures for LIMS and Documentum systems.
• Performed Gap Analysis, FMEA's and product risk analysis to verify that functionality matches the user requirements.
• Developed Remediation Plans for components that were not full and mostly compliant, and conducted related testing to check their compliance.
• Analyzed test scripts to be compliant with 21CFR Part 11 regulations, maintaining validation records and following relevant SOPs.
• Tested the audit trail, data integrity, data security, and electronic signature functionalities of the application.
• Developed Requirements Traceability Matrix (RTM) to keep track of the changing requirements.
• Familiar with FDA design controls, processes, and regulations.
• Developed all SOPs related to the implementation of new products and technologies including operation of manufacturing equipment, acceptance criteria of new raw materials, in-process quality inspections, final product release criteria, and preventive maintenance procedures.
• Revised all process related SOPs in order to assure compliance with new QA regulations and corporate policies.