SUMMARY

• Over all 5 years of experience in Life Sciences Industry as Computer Systems Validation Engineer.
• Skilled at developing and executing Test Plans, Installation/Operational/Performance Qualifications and Summary Reports.
• Excellent documentation, review, and approvals skills in compliance with Validation Practices and Good Documentation Practices (GDP).
• Strong knowledge of Pharmaceutical/Medical device regulations of FDA 21 CFR Part 11, Part 210, Part 211, and Part 820.
• Excellent experience in Cloud (SaaS) based applications such as Veeva Vault.
• Excellent experience in implementing Lab systems such as LIMS.
• Knowledge and experience with automated testing tools - HP ALM.
• Strong knowledge and experience in GxP suites: GLP, GMP, GCP, and GAMP5.
• Working knowledge of Microsoft Office products, LIMS, and Track wise
• Strong knowledge and background of Software Development Life Cycle (SDLC) and Validation Life Cycle (VLC).
• Experience in authoring, reviewing and approving Validation Plan (VMP), User Requirement Specification (URS), Design Specifications (DS), Functional Requirement Specification (FRS), Requirements Traceability Matrix (RTM), and Validation Summary Reports (VSR).
• Extensive experience in documenting, reviewing and approving Installation Qualification (IQ) protocol, Operational Qualification (OQ) protocol, Performance Qualification (PQ) protocol, and Standard Operating Procedures (SOPs).
• Extensive Testing experience demonstrated in developing, reviewing, approving, and documenting Test Plan, Test Cases, Deviations, Change Controls, and Test Summary Reports.
• Experience in performing Gap Analysis, reviewing, and performing Corrective and Preventive Action (CAPA), and suggesting Remediation Plan to mitigate non-compliance.
• Thorough knowledge of Change Control Management Activities, Back-up, and Structured Change Control Procedures.
• Experience in dealing with test scenario creation, test strategy creation, test d Confidential planning & creation, test case creation, test case dry runs, test case execution, defect management and test case and defect closures.
• Excellent organizational, interpersonal, problem solving, technical writing, and oral communication skills.

TECHNICAL SKILLS

• Computer system validation
• GxP: GMP, GCP, GLP
• GAMP5
• Installation Qualification (IQ) Protocol
• Operational Qualification (OQ) Protocol
• Performance Qualification (PQ) Protocol
• Risk Assessment
• 21 CFR Part 11
• Microsoft office

PROFESSIONAL EXPERIENCE

Validation Engineer

Confidential, San Francisco, CA

Responsibilities:

• Executed validation Protocols and prepared final reports for systems according to company requirements and FDA standards.
• Documented Validation Plan to strategize the validation approach as well as test approach in various test cycles.
• Involved in good documentation practice (GDP) of different stages of validation life cycle in compliance with 21 CFR Part 11.
• Involved in end-to-end validation of Medicine Label Printer.
• Competent technical knowledge of facility/utility/equipment/process/cleaning/computer systems validation for solid oral dosage and sterile manufacturing facilities
• Knowledge of industry and regulatory requirements for sterile and non-sterile facilities and processes
• Write and execute validation protocols (, IQ, OQ,PQ,) with little to no supervision as well as to write comprehensive final reports containing thorough resolution of protocol discrepancies. Temperature mapping protocols are a primary focus.
• Created and released required documentation and protocols for FDA regulated products.
• Developed and executed validation deliverables such as Risk Assessment, Instillation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation summary report (VSR).
• Used change controls to introduce modifications to official documents and processes in compliance with 21 CFR 820.
• Performed Gap Analysis to be able to recommend actions to qualify equipment to meet 21 CFR Part 820 requirements.
• Documented Requirements Traceability Matrix (RTM).
• Documented Discrepancy Reports, Discrepancy Logs for the various errors occurred during the testing phase of SDLC.
• Participated in developing the following documents: Validation Plan, Design Specifications, User Manuals, System Procedures, System Description and records for Corrective Action and Preventive Action (CAPA) and Change Control Management (CCM).

CSV Consultant

Responsibilities:

• Performed Validation Testing on the application in accordance with 21 CFR Part 11.
• Updated and implemented Standard Operating Procedures (SOPs) in accordance to company policy.
• Involved in writing and reviewing User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Developed Validation Plan and Summary Reports for LIMS Implementation.
• Responsible for writing Operational Qualification (OQ) protocol of the given modules of LIMS application.
• Developed and analyzed test plans, test scripts and test cases.
• Executed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) documents following GDP guidelines.
• Authored Requirement Traceability Matrix (RTM).
• Created and provided computer validation programs to ensure regulatory compliance.

Jr. Validation Consultant

Confidential, Raritan, New Jersey

Responsibilities:

• Involved in writing Validation Plan, using a comprehensive template.
• Reviewed User Requirements Specifications (URS), Functional Requirements Specifications (FRS) adding 21 CFR Part 11 requirements, and system functionality.
• Performed a risk analysis by considering the severity, probability, and detectability of occurrence.
• Involved in developing and validating of Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) in accordance with FDA standards.
• Started and forwarded the discrepancy management document.
• Involved in Requirement Traceability Matrix (RTM) and final summary report writing process.
• Worked extensively with the QA team for designing Test Plan and develop the Test Scripts for the User Acceptance Testing.

Jr. Validation Engineer

Confidential

Responsibilities:

• Involved in written installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ) protocols
• Reviewed executed protocols to ensure compliance with current industry standards.
• Analyzed Validation Documentation (IQ/OQ/PQ) verifying regulatory compliance
• Developed validation strategies, protocols, and reports.
• Defined validation approach developed protocols (IQ/OQ/PQ) and assisted in validation executions as required.
• Skilled at developing and executing Test Plans, Installation/Operational/Performance Qualifications, Summary Reports, and Design Reviews.
• Write Validation Summary Reports, Requirements Trace Matrices and Standard Operating procedures.

Confidential

Responsibilities:

• Worked as QA tester, my duty was making test case of project and running those test case aster development.
• Basically, I worked on unit test and black box testing area.