PROFESSIONAL SUMMARY:

• 15+ years of diverse experience in Verification and Validation, Computer System Validation, Design Validation, Process Validation, Product Validation, Risk Analysis and Software Quality Assurance in Medical Devices, Biotech and Pharmaceutical industries
• Extensive experience in regulated environments: ISO 13485: 2003 Medical Device Quality Management System Requirements, FDA 21 CFR Part 820 Quality System Regulations, EN ISO 14971:2012 Risk Management, IEC 62304 Medical Device Software - Software Life Cycle Processes, IEC 60601 Medical Electrical Equipment, IEC 6, Medical Devices - Application of Usability Engineering to Medical Devices, 21 CFR Part 11, EU Annex 11, MDD 93/42/EEC), IVDD 98/79/EC, PIC/s, CGMP, GAMP5, ICH, EU, CMS CLIA/CAP, GHTF, SOX, SEI CMM, IEEE, IEC/EN/AAMI, CE mark, FDA 510(k) submission
• Hands-on experience in Class II and III Manufacturing, Industrial Engineering, Process Engineering, Quality Engineering, Packaging Engineering, Supplier Controls, NCR (Non-Conformance Reporting), Design Controls, Risk Management, Root Cause Analysis, Change Controls, Supplier Controls, CAPA, FMEA, Medical Device Reports (MDRs), Adverse Drug Events (ADE's) and Complaint Handling and Reporting, CCB (Change Control Board) and MRB (Material Review Board)

TECHNICAL SKILLS:

Validation Skills: Validation & GxP assessments, FDA QSR, 21 CFR Part 820.30, 21 CFR Part 11, IEC 62304 Software Life Cycle Processes, ISO 9001, ISO 13485 Quality Standard, SEI's CMM, Vendor Audits, Siebel CRM and CTMS, ClinPlus CTMS 2.2, Allegro CTMS, DOORs, Arena PML, Enovia, Oracle Eloqua, Windchill, Oracle Agile PLM (PPM, PQM, PCM, PG&C, EC), SDLC, QAAD Quality Management, MES (Camstar, TrakSYS, Werum PAS-X, STARLIMS), LMS (Saba, Plateau 6.3, ComplianceWire), Filenet, Firstdoc, Documentum, Captiva InputAccel, Veeva, SmartSolve, InSight, Livelink/OpenText, Sharepoint, Argus, ARISg, Oracle AERS, BioClinica, ERP/CRM (SAP, Oracle EBS, Microsoft Dynamics, Workday, NetSuite, Salesforce), EQMS (TrackWise, 123Compliance, Pilgrim, MasterControl, Stratas), GAMP 5, LIMS (LabWare, LabView, StarLIMS, LabCollector, SampleManager), cGMP, GLP, GCP, Dicom, HIPAA, Embedded, Change Control and Configuration Management of cGxP sytems.

Validation Deliverables: Master Validation Plan, Project Plan, Risk Management Plan, Data Migration Plan, Risk Analysis & 21 CFR Part 11 Assessments, User/Functional Requirements, IQ/OQ/PQ Protocols, IQ/OQ/PQ Summary Reports, SOPs, Design Specs, Test Case Authoring, Execution of Test Cases, UAT Test Cases, Requirements Traceability Analysis and Matrix, Regression Impact Analysis, Change Logs, Testability Analysis, Test Summary Logs, Information Protection Plan, Plan, Document Management, Gap Analysis, CAPA, FMEA, Change Control, ERES Assessment, DHF, DHR and DMR.

PROFESSIONAL EXPERIENCE:

Confidential

Validation Program Manager

Responsibilities:

• Leading Thermo Fisher CMD Quality Compliance and Validation for new and existing GxP systems including IT infrastructure, servers, process equipment and information systems per current Good Manufacturing Practices (GMP), FMEA, PHP, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
• Providing design control and software/systems development guidance to Confidential mass spectrometry software development teams to be the single point representative for Design Quality Assurance activities.
• Leading all validation and testing activities on implementation of Oracle EBS Cloud Supply Chain Management and Finance modules and its integrations with Salesforce, LIMS, MES, Veeva Vault Suite.
• Performing as hands-on Validation Engineer authoring and executing SDLC deliverables such as URS, SRS, FRS, DDS, RTM, Unit, Integration, Commissioning Protocols, Manufacturing Equipment Qualification, UAT, Delta V, FAT, SAT, Validation Planning, IQ/OQ/PQ and Validation Summary Report.
• Analyzing business needs to be solved with IT systems and processes used in a GxP environment collaborating with business, quality, and technical individuals to ensure that applications and systems are in compliance with regulatory requirements.
• Applying GAMP 5 risk based approach for risk based validation to determine the scope of validation for GxP systems to develop documentation and validation activities with appropriate justification of the approach.
• Performing FDA 21 CFR Part 11, 820, 210, 211 and EU Annex 11 Gap assessments to assure that the business process is improved and efficiency increased while creating GxP compliant computerized systems.
• Performing as SME on implementation and validation of MasterControl EQMS ensuring implementation plans, CSV, UAT to complete and qualify a system within given constraint of scope, time and schedule.
• Assisting UAT users to execute test cases, and analyze the results. Support tracking of issues and enhancements. Developing User manuals for applications and conduct workshop for the users.
• Developing outlines and support for end - users during and after the implementation process and serving as liaison between business, user community and software developing team.
• Providing QA oversight and assessment for GxP computer systems related deviations, CAPA and change controls to apply risk based methodology to validation efforts.
• Participating in Change Control Board (CCB), reviewing proposed change control, assisting in the validation impact assessment regarding to the changes, generating testing to ensure and document that GxP systems are maintained in the validated state in production.

Confidential, Foster City, CA

IT Systems Validation Lead

Responsibilities:

• Designed, coordinated and executed Oracle EBS DR (Disaster Recovery) annual test exercises for the enterprise integrated applications of Oracle E-Business Suite.
• Prepared Disaster Recovery Standard Operating Procedures and plans, managing IT Disaster Recovery Program partnering with the cross-functional Network/Security/Platform/Database/Application Production Support teams in all aspects of Disaster Recovery.
• Authored, executed and reviewed CSV documents: Validation Project Plans, User and Functional Requirements, Design Specifications, Data Migration Plan, Validation Traceability Matrix, Risk Management tools, GxP and Electronic Records (ER) / Electronic Signature (ES) assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Enhanced Design Reviews, Final Reports and Deviation Handling.
• Performed integration testing that covers business process transaction flow between Gilead Oracle EBS Ecosystem and its boundary applications to be in compliance with GAMP 5 Risk Based approaches, GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for software IQ/OQ/PQ and Standard Operating Procedures.
• Identified in-scope boundary applications for Oracle EBS integration testing for GxP systems: EBS, GEM, OAM, LIMS, Argus, Gilda and non-GxP systems: Brainware, Kronos, GShip, MES, AssureNet, Model N, OBIEE.
• Tested business processes covering Plan to Make (PTM), Procure to Pay (PTP), Order to Cash (OTC), Order to Report (OTR), Account to Close (ATC), Shipping Execution (WSH), Warehouse Management System (WMS).
• Applied GAMP 5 risk based approach for risk based validation to determine the scope of validation for GxP systems to develop documentation and validation activities with appropriate justification of the approach.
• Performed FDA 21 CFR Part 11, 820, 210, 211 and EU Annex 11 Gap assessments to assure that the business process is improved and efficiency increased while creating GxP compliant computerized systems.
• Provided an oversight and assessment for GxP computer systems related deviations, CAPA and change controls to apply risk based methodology to validation efforts.
• Supported and maintaining Quality Assurance programs, policies, procedures and controls ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements and guidelines.

Confidential, Concord, CA

Lead Validation Engineer

Responsibilities:

• Led verification and validation activities providing hands-on leadership across Confidential medical devices system development process for Liberty Automated Peritoneal Dialysis and Hemodialysis Delivery Systems.
• Defined and developed V&V strategy for integrated medical device systems with Electro-Mechanical, Fluidics, Optics, Electronics, Embedded Software and Disposables.
• Authored validation package that includes User Requirements, Functional Specification, Design Specification, Validation Plan, Risk Assessment, Risk Management Plan, Qualification Protocols (IQ/OQ/PQ), Data Migration Plan, Traceability Matrix, Validation Summary Report.
• Ensured V&V documentation compliance with FDA 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, IEC 62304 Medical Device Software Lifecycle, ISO 14971 Risk Management, Medical Device Directive 93/42/EEC, IEC 60601 Medical Electrical Equipment.
• Performed business analysis, requirement gathering and testing for the implementation of SAP MM: Plan to Produce, Shop Floor Execution, SAP and MES Integration, Inventory and Warehouse Management, Functional Integration of Production Planning, Quality Management and Controlling processes.
• Led validation of Trackwise 8.4 CAPA system, track operational information,, changes/change control, deviations, failure investigations and audits.
• Coordinated Verification and Validation, Unit Testing, Code Walkthrough, Functional Black Box/White Box testing, Intended Use/System testing) to ensure that system is validated.
• Contributed to SCRG (Software Change Review Group) and SPG (Software Planning Group) meetings to review defect fixes/proposed changes, implementation schedule and deliverables.
• Coordinated planning and implementation of corrective actions and preventive actions (CAPA) for software and instrument nonconformities.

Confidential, Foster City, CA

Lead Validation Specialist - IT Quality, Security, Compliance

Responsibilities:

• Validation of GxP computerized systems (21 CFR Part 11, Eudralex Anex 11, GAMP 5, SOX, PIC/S, HIPAA, SOPs guidelines) performing testing and validation of multiple applications and systems: TrackWise 8.4, InSight 4.7 to InSight 5.1 upgrade, LMS ComplianceWire, Argus 7, EDMS (FirstDoc and Documentum), Oracle 11.2.0.3 (Data Migration)
• Analyzed business needs to be solved with IT systems and processes used in a GxP environment collaborating with business, quality, and technical individuals to ensure that applications and systems are in compliance with regulatory requirements.
• Used risk-based approach to validation to determine the scope of validation for GxP systems to develop documentation and verification activities with appropriate justification of the approach.
• Participated and guiding the team in preparation of the validation package that includes User Requirements, Functional Specification, Design Specification, Validation Plan, Risk Assessment, Risk Management Plan, Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols, Data Migration Plan, Validation Traceability Matrix, Validation Report.
• Performed validation of data migration on Oracle 11.2.0.3 on Source DB, Target DB and Staging Area. Migration qualification includes set up, pre-migration activities, execution of migration code, collection of migration logs, direct data mapping.
• Managed electronic routing of required documentation ensuring compliance to current procedure for e-approval. Communicating status, solutions, concerns in a timely manner within the team to facilitate and address issues within the projects.
• Participated in Change Control Board (CCB), reviewing proposed change control, assisting in the validation impact assessment regarding to the changes, generating testing to ensure and document that GxP systems are maintained in the validated state in production.

Confidential, San Ramon CA

QA Validation Lead, Enterprise Content Management

Responsibilities:

• Led validation of EMC Documentum D2, setting up enterprise standards for development and validation of Enterprise Level Documents and Content Management Solutions. Full life cycle implementation - from Blueprinting to Go Live and Support.
• Determined the scope of validation that included Content Migration, SAP Integration, Auditing, Reporting, E-Signature, Scanning to D2, Auto:Naming, Numbering, Linking, Virtual Documents, Relationships, Renditions, Dictionaries, Taxonomies, Templates.
• Tested the migration of the legacy systems documents and metadata (FileNet, SharePoint,
• Tested integration of Documentum D2 to SAP Work Management (WM) module that enables enterprises to manage document and data connectivity, and associated regulatory compliance processes within the context of SAP application objects.
• Performed integration testing of Documentum D2/Enterprise Integration (EI) web services built onSOA Architecture using SoapUI 4.6.0 tool to validate web services that utilize standards like XML, WSDL, SOAP and Java Message Service.
• Modified end points, working on different servers (Oracle WebLogic, Apache Tomcat) and different versions of web services.
• Validated the process of Lifecycle Management workflows for automatically promoting files in workflow tasks (Review/Approval, Version Management, Change Control) to the next state in the lifecycle.

Confidential, Palo Alto CA

Sr. Quality Validation Engineer

Responsibilities:

• Led Validation activities for implementation of a new TrackWise 8 system for Global Manufacturing & Supplier Quality Auditing (MSQA), Global Regulatory Compliance (GRC) Submission Planning Application Management.
• Validated custom TrackWise 8.0 CAPA system, track operational information, such as, changes/change control, deviations, failure investigations, audits to facilitate efficient audit and retrieval of information, and to aid in trend analysis.
• Led validation of the upgrade of Documentum 6.5 to Documentum 6.7 with the impact on validating Business Process Management, Web Content Management, enterprise content classification, search and collaboration.
• Conducted software verification and validation activities on Saba LMS application hosted and delivered using a Software-as-a-Service (SaaS) model with an impact on Performance,Network Security, System Backup, Disaster Recovery, Data Integrity .
• Developed and executed investigational and instrumentation characterization protocols for various analytical test equipment, analyzing multivariate results, and preparing summary reports.
• Utilized FDA CFR Part 11 Gap assessments developing and executing CSV remediation plans to assure that business process is improved and efficiency increased while creating GXP compliant computerized systems.

Confidential, Hayward CA

Instrument and Software Validation Lead Engineer

Responsibilities:

• Led testing and V&V activities on OptiScanner, an automated, plasma-based bedside monitoring system that included design verification, V&V of Embedded Control System (Windows CE, VxWorks), Electro-Mechanical, Fluidics, Optics and Software Algorithm.
• Ensured development and execution of Computer System Validation documentation, including Validation Master Plan, Design Specifications, Requirements Traceability Analysis, Test Protocols (IQ, OQ, PQ), Risk Analysis, Traceability Matrix, Summary Reports, SOPs, etc.
• Performed business analysis and testing for SAP APO implementation including blueprint, design, realization and testing. This implementation replaced 3 existing systems (Demand Planning, Supply Planning, and Deployment) and required extensive testing from all businesses.
• Performed as Validation Lead on Documentum 6.7 implementation authoring and implementing Validation Master Plan, URS/FRS, Risk Assessment Plan, Data Migration Plan, IQ, OQ, PQ Protocols, Traceability Matrix and Validation Summary Report.
• Supported quality operations and maintenance of FDA 21 CFR 820, ISO 13485:2003, CMDR SOR 98/282, EU Medical Device Directive 93/42 supporting and establishing QMS compliance to other international medical device s.
• Maintaining GMP documents and standard files, analyzing data, preparing reports, assessing new equipment and auditing facilities for compliance with FDA regulations.
• Performed as a key contact for company Change Control and Configuration Management process for corporate computerized and GMP systems.

Confidential, Alameda CA

Lead Quality Validation Engineer

Responsibilities:

• Led multiple Validation projects like SAP, TrackWise, SuccessFactors, LiveLink, SAP BI, Siebel implementing and following Global Quality procedures, GxP, CFR 21 Part 11, SOX, GAMP 5 and SOP guidelines.
• Led validation of major upgrade of existing Global Quality & Regulatory Compliance (GQRC), CTMS, Quality Management Systems for Internal and External Audit Tracking including validation of TrackWise7.0 core features.
• Authored validation documents for launch of TrackWise system into production using CSV and SDLC methodologies. (e.g. Gap Analysis, Regulatory & Software Risk Assessments, Requirements Specification, Design Specification, Traceability Matrix, UAT Test Plan & Summary Reports, System & UAT Test Scripts, Release Plans, etc).
• Lead validation and support of TrackWise® 7.0, Crystal Reports 11 RAS. Customized over 250 OQ scripts for Calibration Preventive Maintenance for Abbott Labs. Re-engineered over 200 OQ COTS scripts from the Sparta Systems IQ, OQ Validation package using 7.0 SR-5.
• Served as Lead Validation Analyst, collaborating with process owners to capture business requirements and prepare configuration design specifications for several automated.
• Implemented ISO 9001:2008 and ISO 13485: 2003 and associated medical devices standards to perform validation of Quality System Application, IT and infrastructure software (Off-the-shelf and Legacy).

Confidential, Palo Alto CA

Senior Validation Engineer

Responsibilities:

• Performed verification and validation of Confidential medical devices for radiotherapy, radiosurgery, proton therapy, and brachytherapy treatments in compliance with FDA QSR design control requirements 21 CFR Part 820.30, 21 CFR Part 11, IEC 62304 Software Life Cycle Processes, ISO 13485 Quality Standard and HIPAA.
• Authored Validation Documentation: Validation Plans, System Requirement Specifications, URS, FRS, IQ/OQ/PQ Protocols, Traceability Matrix, Risk Assessment Plans and SOPs.
• Led validation for implementation of Documentum 6.5 a document management system to organize, control, access enterprise content, business process and electronic records.
• Authored validation documents for launch of TrackWise global regulatory submission assessment and remediation project. (Val. Plan, Req./Design Spec, Configuration & UAT.
• Analyzed data and preparing final reports for various GxP systems: Mgr/Pro, LabWare LIMS, Supplier Assessment Material Management System, dsNavigator, Plateau system.
• Developed and maintained internal audit program, including planning and performing audit activities, ensuring timely performance of scheduled audits, and issuance of reports/findings.

Confidential, Davis CA

Staff Validation Quality Engineer

Responsibilities:

• Provided Computer System Validation expertise to assigned projects (Documentum 6.7, SharePoint, Workday) including managing validation projects, developing system life cycle documentation, and provide consultation on CSV projects.
• Ensured development and execution of Computer System Validation documentation, including Validation Master Plan, Design Specifications, Requirements Traceability Analysis, IQ, OQ, PQ, Test Protocols, Risk Analysis, Traceability Matrix, Summary Reports, SOPs and other related documents.
• Performed in-house Software Quality Assurance. Authored Unit Testing Protocols, Integration Testing Protocols for software validation. Executed system test plan for Microsoft VSTO based software application including functional, usability, performance, load / stress tests.
• Responsible for maintaining GMP documents and standard files, analyzing data, preparing reports, assessing new equipment and auditing facilities for compliance with ISO regulations using QAAD Quality Management System.
• Worked closely with other groups such as regulatory, document controls, manufacturing operations, customer service and engineering to ensure compliance and efficiency.

Confidential, Santa Clara, CA

Senior Validation Engineer

Responsibilities:

• Performed Verification and Validation of medical devices, VISX WaveScan and STAR Excimer Laser Systems that calculate laser vision correction treatment of the human eye and perform computer-controlled laser vision correction surgery.
• Performed Verification and Validation of laser software development process. Activities conducted to ensure that the Design control process is in compliance with applicable standards and regulations, including FDA QSR, ISO9001, EN46001 and MDD.
• Lead validation for upgrade of existing TrackWise Quality Management Systems to version 7.0 SR5 including configuration of new 7.0 functionalities. Developed custom Crystal XI reports for TrackWise CAPA, Audit, Deviation and Change Control modules.
• Validation of in-house Confidential t Information Management System (PIMS) that tracks Confidential t records, Confidential t vital signs, medication, allergies, problems, doctor notes and consultations.
• Developed flowchart and wrote SOP of defect tracking process to support regulatory requirements for SDLC test phase using Quality Center