Eric Johnson Email & Phone Number

• Over 7 years of experience as a validation engineer in Biopharmaceutical and medical device industry with expertise in computer system validation (CSV) and testing and technical writing.• Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC). • Familiar with FDA regulations such as, Title 21 CFR Part 11, Annex 11, 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820• Good understanding of various life cycle methodologies like Water Fall, V-Model and Agile.• Reviewed and developed validation deliverables- URS, FRS, Requirement traceability matrix (RTM), IQ, OQ and PQ protocols in compliance and conformance with FDA rules and regulations.• Skilled in developing Standard Operating Procedures (SOP’s), policies and working instructions to comply with FDA regulations• Experience in Executing Test Plans, Test Procedures, Test Scripts, Test Cases, Test requirements and testing standards.• Experienced in preparing Risk Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.• Maintained proper change control documentation in accordance with SOP’s, and comply methodology in Trackwise and Trial Master File (TMF)• Assisted in validation of Web Services, Reports and TrackWise coordinator function for different modules of TrackWise. • Excellent experience in validating wide variety of applications and infrastructure - Excel spreadsheets, Track Wise, LIMS, EDMS.

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  Senior Validation Engineer

  Southern Research

  May 2016 - Present

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  Lamar University

  Mechanical Engineering