Professional Profile

** ***** ** ******** ******* and Software Validation. 14 Years of experience in Medical Device, Pharmaceutical, and Life Science.

DEA Code of Federal Regulations Title 21: Part 1300 to End, FDA QSR 820(Quality Systems Regulations), ISO 9000-9001, ISO 13485, IEC-62304, CMDAS, FDA 510(K) Requirements, cGxP, GDP, HIMS, Medical Device Class I II III, CAPA, COTS, Critical Path Analysis, Electronic Batch Reporting, FMEA, 21CFR Part11,Part 210, Part 211,Part 280, Part 803,Part 820,GMP, GAMP5, GLP, GS1, GCP,CAPA, Annex 11, AC:2008 Medical Device Software Compliance, ICH Q7,ICHQ9, ISO 14971 Risk Management for Medical Devices, US/HMO, UL/ETL/IEC standards, European Guidelines on Medical Devices Vigilance System, Six Sigma Process Validation.

Equipment/System Expertise

ERP, EtQv6.0,9.0,11.0, Documentum, Master Control, PeopleSoft, SharePoint,Gerber, EDMS, QMS, SOA, SQL Server, SharePoint, LabWare, MAXIMO 6.2, ASP, Seimens InfoSystem HVAC, QT-9 Electronic Document and Data Control System, SAP, Open VMS, Citrix, Epic, DB2, ORACLE, HP-UX, AIX,

HIMS, QSR, Hl7, LIMS, Johnson Controls Metasys BMS Rockwell Process Control Systems FactoryTallk View.

Professional Experience

STAAR Surgical Sr. Validation Engineer, SME Consultant 01/15-05/16

Provided technical direction and hands-on assistance for testing projects, such as test planning, case development, test execution and reporting.

SME for systems qualification and software validation under FDA regulations.

Performed validation on QMS,BMS Systems Software COTS, Process Control Systems utilizing PLC’s, Equipment Commissioning and LIMS

Commissioning Equipment and LIMS validation, packaging and labels.

Validation of Inspection Program and Test Methods

Assessed and performed Critical Process Path validation

Validation and Implementation of BMS, EDS, and QMS

Performed 21CFR Part11 validation on BMS, EDMS, and QMS

Member of the Validation Oversight Committee

Provided Process Leadership for industry best practices

Responsible to review Commissioning documents, Systems and Software Validation packages before FDA submission.

Drafted SOP for Software and Systems Development LifeCycle

Performed FMEA before validation

Wrote and executed barcode, label and thermal printer validation

Performed successful Systems and Part11 validation of the Online-Calculating Ordering System for new business.

Cody Laboratories (A Lannett Company), Sr. Software Validation/Project Engineer Consultant, 01/14-12

14

Sr. Software Validation Engineer for a Bulk Pharmaceutical Manufacturer of Schedule I and Schedule II drugs for Active Pharmaceutical Ingredients (API’s) under cGMP conditions.

Provided leadership and technical decision making for Management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities.

Approved system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities.

Designed and executed Validation Plans and Programs for new and improved pharmaceutical manufacturing processes and products.

Provided provide QA and Validation Engineering support to new and existing Pharmaceutical Manufacturing Operations.

Responsible for the Installation, Operation, and Performance Qualifications of new and existing equipment and processes as dictated by the FDA to ensure reproducible production.

Consulted on the authoring and conformance of validation-related deliverables and activities in regard to corporate SOPs and current regulations.

Preformed CSV under GAMP5 Compliance and Regulations.

Developed, Implemented and Trained Staff on Validation Standard Operating Procedures.

Authored Remediation Plans and Master Validation Plans for all CSV GxP projects

Performed 21CFR Part11, 820 Validation on all GxP systems.

Johnson & Johnson Advance Sterilization Products, Sr. Software Validation/Project Engineer, 03/13-01/14

Managed and performed FDA software validation activities on all project modules under the Back-To-Basics (BtB) ERP system.

Monitored and participated in all product software design, development, verification and validation (V&V) activities to ensure that software is implemented in accordance with established regulatory and company requirements and that the process is carried out in accordance with established procedures.

Lead and insured completion of Risk Management Activities. Determine risk & risk mitigations.

Executed Compliance Assessments to determine project compliance requirements.

Performed projects audits to achieve GxP on GDP and GCP in accordance with regulations.

Performed Risk Assessments under FMEA. Opened CAPA’s to ensure adequate validation under IT SDLC Methodology.

Authored and executed Master Validation Plans for all systems validation.

Reviewed and validated each project’s URS and FRS.

Provide quality assurance oversight for system related issues (deviations, incidents, etc.)

Reviewed all test protocols and test cases for completeness and accuracy.

Designed the Traceability Matrixes referencing requirements to test case coverage.

Participated in the review of product requirements, design requirements, software requirements specifications, functional specifications, software test specifications, and test data & reports.

Authored and executed project modules IQ, OQ, and PQ validation protocols.

Performed the IQ,OQ, and PQ Validation Reporting

Resolved issues related to project status and business needs; facilitated meetings between senior management, business owners and developers.

Performed Validation, Data Integration, and Backend testing using SQL Queries; assist with Performance and Stress Testing.

Alere HealthCare Management Solutions, Sr. Software Validation/Project Engineer, 06/12-02/13

Managed and performed the validation activities of HemoSense Multiplexer3+ Software Package, used for calibration and measurement of INRatio Coagulation Meters. Class III

Created Project Plan, Work Breakdown, and define the project; assist with project scope, risk assessment, budget analysis, resource utilization, and timelines.

Authored User Requirements Specifications (URS), Validation Plans, Protocols IQ, OQ, PQ, test scripts, deviations and final test reports as well as all documents to support software validation plans and protocols.

Performed IQ, OQ, and PQ validation activities.

Enforced product release Configuration Management procedures.

Participated in Product Life Cycle Phase and Peer Reviews.

Lead and insured completion of Risk Management Activities. Determine risk & risk mitigation, carried test metrics, set project scope, set & ensured adherence to quality standards.

Responsible for reporting test status, defect testing status and test planning activities on weekly basis and as required to QA management.

Established and improved product/process quality individually and through team collaborating efforts.

Lead defect review meetings, assist with recording, tracking, prioritizing, and closing bugs.

Resolved issues related to project status and business needs; facilitated meetings between senior management, business owners and developers.

Managed Change Control process; lead meetings to discuss the impact of Change Requests.

Worked with cross-functional teams to assure their product development, verification and validation activities and the resulting work products were in compliance with applicable regulations and standards.

Exercised deep subject matter/functional expertise and process skills to assist internal customers and stakeholders identify and meet high priority needs.

Posey Company, Sr. Software Validation/Project Engineer, 05/10- 06/12

Primary point of accountability to Business partners for the management and implementation of small to medium sized projects that support achievement of moderate to complex units and corporate goals.

Responsible for managing and performing the Medical Devices software certification, verification and validation of Class I, II, III Medical Devices, Firmware and Computer Systems Validation.

Provided leadership and technical decision making for Executive Management and High level technical Personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic activities.

Created Project Plan, Work Breakdown, and define the project; assist with project scope, risk assessment, budget analysis, resource utilization, and timeline according to Six Sigma standards.

Identified significant opportunities for improvement (cost, cycle time, quality, etc.) that were complex or involve multiple organizational areas.

Analyzed feasibility procedure and participated in developing, executing, or monitoring implementation plan.

Managed Change Control process; lead meetings to discuss the impact of Change Requests.

Resolved issues related to project status and business needs; facilitate meetings between senior management, business owners and developers.

Tracked and organize tasks and objectives using Microsoft Project; assign tasks to each member of the teams.

Identified Design Control Activity for the following activities:

Design Output Review

Drawing Releases (Change control defined by Pre-production Design or Change Procedure)

Process Design and Development (Cost review of the part and process. Project schedule)

Creation of the Quality Plan (Creation of the test system requirements)

Process Implementation (Develop and assemble of test systems)

Creation of the Quality Plan under Design Failure Mode and Effect Analysis (FMEA)

Responsible for developing and overseeing the development of all required validation documentation including: Validation Plan, Functional Requirements, Design Document, IQ/OQ/PQ protocols and associated test scripts, Validation Summary, and Trace Matrix.

Provided Interpretation and application of FDA regulations as they pertained to GxP computer systems.

Produced the validation schedule and estimates.

Represented the organization in contacts with regulatory agencies, including interface with FDA investigators.

Provided QA Support in Root Cause Analysis and CAPA investigations.

Reliance EtQ, Gerber, GMP, GLP, GCP, AC:2008 Medical Device Software Compliance, SQL Server, SmartSolve SmartCAPA™, SmartDoc™, SmartTrain™ and SmartAudit™, 62304 © IEC:2006, FDA 21 CFR Part-11,Part-280, Part 820,Visual Studio, SQL 2000, QSR (Quality Systems Regulations) Agile Methodology.

Allergan Inc., Sr. Software Validation Engineer Specialist, 08/08- 04/10

Completed validation of hybrid version of Documentum's, Scientific Data Management System (SDMS) for implementation for FDA 21CFR compliance.

Performed Installation Qualification Protocols, Operational Qualification Protocols and Performance Qualification Protocols validation for the First Doc Clinical Documentum System.

Performed Validation, Data Integration, and Backend testing using SQL Queries; assist with Performance and Stress Testing.

Defined test plans for product design verification and validation.

Created the testing strategy and test plans for testing all affected business systems; ensure traceability of requirements to test plans and influence appropriate levels of ongoing requirements management.

Coordinated efforts of the project team, business users, and test teams to develop test data and test requirements; ensure setup and availability of the validation environment.

Collaborated with development and business analysts to have defects and product ease-of-use issues addressed.

Collaborated with technology and business leaders to identify opportunities for process improvement.

Documentum, PeopleSoft, EDMS, GMP, GLP, GCP, SQL Server, Test Director, FileMaker Pro 8, HL7, FDA, 21 CFR Part-11,Part-280, Part 820,LabWare, LIMS, SQL 2000, QSR (Quality Systems Regulations) Agile Methodology.

Abbott Vascular, Sr. Software Validation/ Project Engineer Enterprise Resource Planning/Asset Management Integrating Global Operations, 06/05- 08/08

Managed and performed the validation activities of the implementation of the Global Asset Management System in an FDA regulated environment.

Responsible for performing software validation on Class II & III Medical Devices, Firmware and Computer Systems Validation.

Created Project Plan, Work Breakdown, and define the project; assist with project scope, risk assessment, budget analysis, resource utilization, and timeline according to Six Sigma standards.

Established plans, methods, and procedures to ensure the timely completion of projects.

Defined test plans for product design verification and validation.

Coordinated and managed reliability test programs, managing and coordinating engineering testing activities.

Developed and managed functional, integration, and unit testing schedule, work breakdown, and estimates (based on requirements) that support the overall project schedule. Manage/track project effort to estimates and schedule.

Transitioned End User Support services from an outsourced vendor to in-house support, realized a 20 percent cost savings.

Implemented and managed procedures for Design Control for the basis for Design Validation

Performed IQ, OQ, and PQ systems validation of 21CFR Part 11 Closed Systems on COTS, CAPA Management System and Returned Materials Authorization System.

Provided QA Support in Root Cause Analysis and CAPA investigations.

Performed Risk Analysis, Failure Modes and Effects Analysis (FMEA).

Developed SOPs and work instructions to optimize system usage and business applications.

Created the testing strategy and test plans for testing all affected business systems; ensure traceability of requirements to test plans and influence appropriate levels of ongoing requirements management.

Coordinated efforts of the project team; business users, and test teams to develop design controls and test requirements; ensure setup and availability of the validation environment.

Collaborated with development and business analysts to have defects and product ease-of-use issues addressed.

Documented and maintained Functional test scripts from business specifications and from design changes.

Represented the organization in contacts with regulatory agencies, including interface with FDA investigators.

Supported User Acceptance Testing.

MAXIMO Enterprise Asset Management (EAM) 6.2 Remedy, PeopleSoft, 62304 © IEC:2006, HP Quick Test Pro 9.0,HP QA Center, Visual Studio, GMP, GLP, GCP Six Sigma Process Validation, SQL Server, ASP Sarbanes-Oxley, Test Director, FileMaker Pro 8, HL7, FDA, 21 CFR Part-11, Part-280, LabWare, SQL LIMS, SQL 2000, QSR (Quality Systems Regulations.

Quest Diagnostics - Advance Clinical Trials, Sr. Software Validation Engineer Specialist, 01/04-05/05

Performed Software Quality Assurance Testing and product support for the Advance Clinical Trials Division.

Administered Functional Testing, Regression Testing, Integration Testing, Fault Recovery Testing.

Prepared standard validation documentation such as Installation Qualification Protocols, Operational Qualification Protocols and Performance Qualification Protocols for the Global SQL*LIMS application.

Participated in and supported the execution of SQL LIMS validation activities.

Preparation of the Installation Qualification Protocols and IQ Test Cases

Functional Gap Analysis of the existing OQ/PQ Test Cases

Preparation of the Operational Qualification Protocol and OQ Test Cases

Preparation of the Performance Qualification Protocol and PQ Test Cases

Preparation of the Traceability Report

Preparation of the Qualification Plan

Collaborated with development and business analysts to have defects and product ease-of-use issues addressed.

Documented and maintained Functional test scripts from business specifications and from design changes.

Provided Organizational Planning and Technical Support to Quest Diagnostics Business Units

Provided QA Technical Metrics Reporting, Site Metrics Reporting, and Capacity Analysis.

Served as a Technology Vendor Liaison for the Business Units.

HP Quick Test Pro6.5, Test Director, FileMaker Pro 8,Citrix, Meditech, HL7, IQ, OQ and PQ Validation, 21CFR Part 11, Part 280, GMP, GLP, GCP SQL 2000, Six Sigma, LabWare, SQL LIMS, Weblogic 6.0, HP Quick Test Pro 6.5, Test Director, SiteMinder, Link Check, Empirix OneSight/Farsight, E-Test,.NET, Apache, Oracle9i.

B. Braun, Sr. Project Engineer / Project Manager 08/00-07/03

Designed and executed Master Validation Plans and Programs for new and improved pharmaceutical manufacturing processes and products.

Designed and implemented Quality Control and Quality Assurance systems for new and existing pharmaceutical manufacturing processes and products.

Reviewed business requirements and systems analysis specifications against existing computer system capabilities, workflow, and interfaces for adequacy and viability of development implementation.

Interfaced with Management personnel in Engineering, Manufacturing, Regulatory Affairs, and other technical disciplines to represent QA/Validation in project teams, with the objective to assure that project quality objectives were met.

Created test plans and develop corresponding test cases for originations systems, web based applications and stand-alone applications as scoped for each target release.

Administered Functional Testing, Regression Testing, Integration Testing, Performance, and Fault Recovery Testing.

Design and implement Quality Control and Quality Assurance systems for new and existing pharmaceutical manufacturing processes and products.

Executed manual and automated tests using approved QA tools.

Validated defect fixes and other change implementations according to specifications.

Provided test reports indicating the results of testing and product stability including recommendations concerning the release of the product.

Formulated recommendations for disposition or other actions related to product nonconformance and field performance issues.

Collaborated with development and business analysts to have defects and product ease-of-use issues addressed.

Managed project tasks, schedules, scope change and deadlines to eliminate constraints and ensure that company needs are met.

Rational Unified Process; Clear Quest, ClearClase, ASP.Net, SQL 2000, Agile, PVCS Tracker, Mercury Test Director, Oracle Reports, Test Director, Load Runner, Websphere, Universe, .NET, HTML, XML, SQL, Java2EE, Visual Source Safe.

DIRECTV, Sr. Software QA Analyst, 1996-7/00

Administered Functional Testing, Regression Testing, Integration Testing, Fault Recovery Testing.

Performed Load and Performance Testing, within the Quality Assurance test certification process.

Performed white box testing on API’s and stored procedures.

Functioned as a technical liaison between the business units and the technical IT staff under the guidance of the project manager.

Developed the QA test strategy and spearheaded the QA Test certification efforts.

Implemented software test policies and procedures.

Performed software test environment setup and configuration.

Devised and wrote System and Subsystem functional requirements from the Critical Design Review.

Performed QA and Acceptance Testing on On-Line-Applications with Vendor Software.

Executed unit test in C, C++ code.

Assisted the Development Team in participation of Design Reviews and code walkthrough.

Implemented test methodology for the Year 2000 test group.

Assisted in creating the methodology of migrating Year 2000 files into the production environment.

Collected business requirements and utilized data/work flows and processes.

Produced and distributed the Systems Operators Manual and System Summary documentation to the broadcast sites and affiliates upon system certification.

UNIX/C, Solaris, Java, OOD,UML, HTML, XML, NFS, SQL, Rational ClearQuest, Test Director, PVCS Tracker, Oracle Custom Development Methodology. Solaris, HTML, XML, OOD, Java, HTTP, NFS, Client-Server, C, C++, Rational SQA 6.1, MS-Project, ISO 9001 Methodology.

Bank of America, Quality Assurance Analyst, 1/94-9/96

Provided QA support in the Institutional Trust and Security Services Division.

Administered Function, Regression and Acceptance testing.

Defined Acceptance and Regression Test phases both entry/exit criteria.

Maintain and provided administrative support for TCP/IP and Novell Netware.

Created document and maintained test cases and appropriate test scripts.

Worked with customers and senior management to define code access and customer requirements.

Administered Quality Assurance Testing for Year 2000 compliancy.

Responsible for the setup and configuration of the Year 2000 test environment.

Performed QA and Acceptance Testing on On-Line Applications and vendor software.

Evaluated and benchmarked automated software test tools.

Responsible for tracking software incidents to problem resolution.

Created test scripts and validated testing in both batch and on-line test configurations

Reviewed and recommended upgrades to test processes and deliverables.

UNIX/C, Client-Server, MS-Project, Timeline, Excel, MS-TEST. OS/390, DB2, UNIX/C, Solaris, Client-Server, TSO, PVCS Tracker, MS-Project, MS-Word, Excel, SQA Teamtest, Compuware Playback+, Mercury Win-Runner, Test Director.

EDUCATION

B.S. ELECTRONICS ENGINEERING

WEST VIRGINIA UNIVERSITY INSTITIUTE OF TECHNOLOGY

TRAINING

DEA Code of Federal Regulations Title 21 Part 1300 to End,QSR 820(Quality Systems Regulations

HIMSQSR21CFR Part 11, 820), ISO 9000-9001, ISO 13485, IEC-62304, CMDAS, FDA 510(K) Requirements, HIMS, Medical Device Class I II III, CAPA, COTS, Electronic Batch Reporting, FMEA, 21CFR Part11,Part 210, Part 211,Part 280, Part 803,Part 820,GMP, GAMP5, GLP, GS1, GCP,CAPA, Annex 11, AC:2008 Medical Device Software Compliance, ICH Q7,ICHQ9, ISO 14971 Risk Management for Medical Devices, US/HMO, UL/ETL/IEC standards, European Guidelines on Medical Devices Vigilance System, Six Sigma Process Validation.

PROFESSIONAL ASSOCIATIONS

ASQ

IEEE

IVT

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