Validation Engineer Resume Austin, TX - Hire IT People

SUMMARY

4+ years of experience in a Computer Systems Validation (CSV) and technical writing.
Experience in developing Validation Plan, Validation Summary Report (VSR), Requirements Traceability Matrix (RTM), and creating Standard Operating Procedures (SOPs) and Work Instructions (WIs).
Experience with Learning Management Systems (LMS), Quality Management System (QMS), and Electronic Document Management Systems (EDMS).
Reviewed Testing documentation - Test Procedures, Test Plans, and Test Scripts and Test Summary Reports.
FDA regulations 21 CFR Part 11 (Electronic Records, Electronic signatures and Audit Trails).
Utilized risk-based approach to developing and testing.
Reviewing and approving User Requirements Specifications (URS), Functional Requirements Specification (FRS), Test Plans and Test cases.
Experience in conducting Risk Analysis, and Gap Analysis
Knowledge on HP ALM.
Ability to manage multiple priorities in a fast-paced environment.
Good communication and Technical Writing Skills.

TECHNICAL SKILLS

Computer Systems Validation (CSV): 21CFR Part 11, 210/211 and 820, GxP (cGMP, GCP, GLP), IQ, OQ, PQ, RTM, URS, FRS, SOPs, Summary Reports, Audit Trails

Technical Writing: Validation Master Plan (VMP/VP), Functional Specifications (FS), Design Specification (DS), Requirement Traceability Matrix (RTM), Test Plans, Test cases, Test Summaries, GxP compliance report generation, software documentation. HP ALM, TrackWise, eDocs, SharePoint, ComplianceWire, and Veeva Vault

MS Office: Word, Excel, PowerPoint, Outlook, Access, OneNote

Programming Language: SQL, HTML, JavaScript, Python, PHP.

PROFESSIONAL EXPERIENCE

Confidential, Austin, TX

Validation Engineer

Responsibilities:

Assisted in developing the Validation Plan.
Worked on Quality Management System (QMS)-TrackWise (Change Management Module)
Reviewed and commented User Requirements specifications, Functional Requirements specifications document, in compliance with 21 CFR Part 11 Requirements.
Responsible for writing and executing Installation qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols.
Performed Risk analysis as in FMEA.
Created the Requirement Traceability Matrix (RTM) for the application.
Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP)

Confidential, NC

Validation Analyst/Computer Systems

Responsibilities:

Worked on Electronic Document Management System (EDMS)-Veeva Vault (Home, Create and Search module)
Authored test protocol, test script, for IQ, OQ, PQ.
Reviewed and Executed the prepared protocol by following good document practice GDP and reported any discrepancies found.
Drafted the traceability matrix to keep track of all the requirements and test script and ensure all the requirements are tasted.
Participated in (RRA) Requirements Risk Assessment to find out potential risk in the system and to come up with a Risk Mitigation plan on validation.
Drafted validation summary report to summarize the validation results.
Implemented GxP (GMP, GCP, and GLP) and GAMP guidelines in the systems.
Involved in preparation and documentation for all requirements of the computer system validation based on a risk-based approach, to ensure compliance in accordance with Regulatory requirements.
Developed & proposed a Quality Agreement standards & template for suppliers & sites for validation & data integrity.
Coordinated with the quality assurance team in updating and maintaining the SOPs for laboratory equipment.

Confidential, Piscataway, NJ

Jr. Validation Engineer

Responsibilities:

Undergone thorough company training and learned to Develop IQ, OQ and PQ protocols, reviewing and executing them.
Worked on Compliance Learning Management System- ComplianceWire (To-do, History and Catalog module)
Maintained Requirement Traceability Matrix (RTM) for the application
Assisted in documentation system with FDA CFR 21 Part 11 compliance
Attended the Kick-off meetings and successfully accomplished the tasks according to Plan of Action.
Assisted System Manager in Compliance work related projects using SharePoint and MS-Excel.

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Validation Engineer Resume

Austin, TX

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