Technical SME for Qualification and Validation of equipment, facilities, utilities and computerized systems. Developed strategies and implementation for the build and test and of the system lifecycle following the Genentech Pharmaceutical Quality System (PQS). Prepared Site Validation Master Plans, Project Plans, Test Plans and Test Cases for scope of qualification and validation. Authored and review as technical SME for Risk Management documentation (Impact Assessment (SIA), Criticality Assessment (CA), and Risk Assessments (RA)) and other lifecycle documentation. Collecting samples and analyzing test results and preparing Qualification Summary Reports. Provide technical assessments and qualification/validation impact reviews for engineering process and standard operating procedure changes. Coordinated plans and testing activities within site groups including: Technology, Manufacturing, Maintenance and Quality organizationsSite SME for Pharmaceutical Quality implementation of Data Integrity Authored technical report for family approach grouping strategy for all site process equipment to reduce total number tests for an established family