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).Senior/Lead Engineer in Verification, Validation, Test, SQA, CSV, FDA QSR, ISO, GxP, GAMP5, CSV, Quality and
• Regulatory Compliance, ERP, SAP, EQMS, EDMS, CTMS, LIMS, PLM, LMS, Pharmacovigilance, Software & Instrument
• Pharmaceuticals, Medical Devices, Biotechnology

TECHNICAL SKILLS:

Validation Skills: 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, ERP/CRM (SAP, Oracle EBS, Microsoft Dynamics, Workday, NetSuite, Salesforce), EQMS (TrackWise, 123Compliance, 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, Training Plan, Document Management, Gap Analysis, CAPA, FMEA, Change Control, ERES Assessment, DHF, DHR and DMR.

PROFESSIONAL EXPERIENCE:

Confidential, Hercules, CA

IT Systems Validation Lead

Responsibilities:

• Designing, coordinating and executing SAP testing for the enterprise integrated applications of SAP ERP.
• Authoring 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.
• Preparing 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.
• Performing integration testing that covers business process transaction flow between Gilead Oracle EBS Ecosystem and its boundary applications.
• Identifying in-scope boundary applications for SAP integration testing for GxP systems: SAP, GEM, OAM, LIMS, Argus, Gilda and non-GxP systems: Brainware, Kronos, GShip, MES, AssureNet, Model N, OBIEE.
• Testing 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).
• 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.
• Providing an oversight and assessment for GxP computer systems related deviations, CAPA and change controls to apply risk based methodology to validation efforts.
• Supporting 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 Engineer, System Verification & Validation

Responsibilities:

• Led verification and validation activities providing hands-on leadership across Confidential medical devices system development process for Confidential 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, training, 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 Engineer - 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, 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 Confidential 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, Santa Clara, CA

Senior Validation Engineer

Responsibilities:

• Performed Verification and Validation of medical devices, Confidential 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 Patient Information Management System (PIMS) that tracks patient records, patient 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