Kevin R. Whytus 904 Highland Oak Drive, Dallas, TX 75232 (951) 515 9959 | kw15c80ce@westpost.

net VALIDATION ENGINEER Accomplished Validation Engineer with extensive process development and computer system validation in medical device firms, pharmaceutical industries and Fortun e 500 transportation firms. Proven history of performing and leading teams to co nduct engineering initiatives that ensure compliance with current GMP requiremen ts. Perform research on equipment and process improvements, develop implementati on plans and execute within tight deadlines and stated budgets consistently. Cle ar, diplomatic communicator, collaborative vendor liaison, effective project man ager and proven validation engineer Capital Expenditure Requirements Project Management & Planning Vendor Assessment, Selection & Management Computer System Specifications System & Software Validations Operational Excellence & Quality Assurance FDA & Corporate Audit Participation Process & Procedure Documentation Equipment Installation and Qualification Talent Management & Leadership

ENGINEERING & TECHNICAL COMPETENCIES Engineering Protocols & Systems: 21 CFR Part 11, 210, 211, 820, ISO 9001 | cGMP requirements | Experiment Design using Taguchi Techniques and Capability Studies , Systech/Nutec Vision Systems, Client/Server Database Systems such as Siemens A pogee/Infocenter Suite, MG Encapsulation systems, Glatt Fluid Bed Granulation sy stems and Fette Tablet press systems, Uhlmann Blister Machines, Human Machine In terface, Beckman UV-Vis, Agilent GC Chromatography, Empower, Trackwise, SAP PM a nd Multi-Dose Systems. Technical: AutoCAD | MS Word, Excel, PowerPoint, Project, File Management | Wind ows XP WATSON LABORATORIES, INC. Corona, CA 2001 current Engineer Principal - Engineering & Manufacturing (1/10 current) Coordinate the development of configurable software between vendor and manufactu ring operations areas and managed one employee and six vendor representatives to meet department objectives and goals. Develop user requirements and functional specifications for equipment computer s ystems and client/ server computer systems to meet company standard operating pr ocedures, GAMP 5 and 21 CFR Part 11. Directed project to implement new bottle capper, retorquer and labeler on two bo ttle filling packaging lines to improve Overall Equipment Efficiency (OEE) to 70 %. Participated on Global Standard Operating Procedures Team to develop Computer Sy stem Validation (CSV) and Environmental Monitoring procedures that meet European Union and FDA regulations.

Implemented and managed $500,000 modification to datacenter heating ventilation air conditioning (HVAC) and electrical systems to ensure that state and city cod es were met. Developed project plan and failure mode effect analysis on packaging equipment t o prevent undercount tablets. Led upgrade implementation of Human Machine Interface (HMI) to empower mechanics to control equipment. Developed and managed $13MM capital expenditure for manufacturing site improveme nts to equipment, facility and utilities to meet company objectives. Participated in FDA and third party audits while under consent decree to success fully defend manufacturing site qualifications, computer validation (21 CFR Part 11) and facility/utility modifications. Serve as Equipment System Administrator for inspection systems and various clien t/server database systems. Troubleshoot and implement changes to Programmable Logic Controllers (PLC) to im prove an OEE to 68%. Manager, Qualification - Engineering (6/07 1/10) Supervised eight consultants and three direct employees to perform Computer Syst em Validation Projects. Managed and maintained $336,000 budget for qualification contractors to remediat e, upgrade and perform Computer System Validations on variety of systems Reduced overtime associated with preventive maintenance by developing and implem enting Criticality Assessment SOP and methodology to classify equipment and util ity systems as Critical and Non-Critical. Decreased the cost of product by automating assembly of $3MM oral contraceptive packaging line. Specified, purchased, installed and qualified label inspection system that reduc ed reconciliation of packaging lots for seven packaging lines. Assigned and closed Corrective Action Preventive Action (CAPA) and Deviations to ensure company remained compliant with FDA regulations. Successfully defended C SVs during FDA, Third Party and Corporate Audits. Developed Statement of Work (SOW) and Request for Proposal (RFP) to obtain outsi de contractor resources. Interacted with IT project managers to develop validation schedules and budgetin g of validation resources Performed, reviewed and approved Vendor Audit of software companies Engineer Principal, Engineering Validation (6/05 6/07) Supervised a group of up to six (6) Consultants and two (2) direct employees in performing Equipment, Utility and Computer System Validation Projects such as in itial validation, remediation and modification.

Supported compliance audits by presenting and answering questions for qualificat ion documents during FDA, corporate and product acceptance inspections. Implemented and performed equipment qualification that reduced manufacturing cyc le time by 25%. Managed Computer System Validation of Caliper Lifescience Tablet Processing Work station system for 20 users, which automated tablet processing for laboratory op erations. Streamlined procedures for equipment/utility qualification and CSV using risk as sessment and standardization. Managed a budget for contracted resources and served as a liaison between vendor s and firm user groups. Senior Engineer, Engineering Validation (1/03 6/05) Coordinated the development of configurable software between vendor and manufact uring departments. Managed four contractors to validate the Empower Data Acquisition Chromatography System for 50 users. Contributed to validation of SAP PM module for thirty end users and streamlined preventive maintenance. Participated on a team to perform Computer System Validation of Trackwise Change Control/Deviation and CAPA module for one hundred (100) end users and streamlin ed process of Preventive Maintenance. Engineer, Engineering Validation (8/01 1/03) Prepared and reviewed Computer System Specifications. Initiated, executed and re viewed Software Validations. Generated and reviewed Final Reports that documente d the results of protocol testing. Reviewed and approved Equipment Qualifications Protocols and Final Reports which document PLC or Automated System software including SCADA. Managed a budget for contracted resources. RETRACTABLE TECHNOLOGIES, INC. Little Elm, TX 1999 2001 Quality Assurance - Validation Engineer Implemented a software quality assurance plan and software validation SOP for mi ssion critical systems , such as RSLogix 5/500, PanelBuilder 32/1400e, and docu ment control software, to comply with 21 CFR Part 11. Initiated, performed and executed engineering studies, design of experiments, in stallation qualification, operation/process qualifications, corrective action ac tivities and software validations. Lead programmers in the development of training and laboratory information manag ement systems software. Specified, purchased, executed and validated $100,000 in laboratory instrumentat ion across a 1-year period. MENTOR H/S, Irving, TX 1997 1999

Associate Engineer/Equipment Engineer

(AutoCad v12/13)

Performed equipment, process, software validations and control system qualificat ions. Designed production use tooling and created electrical schematics and equipment illustrations for protocols. Performed tasks required investigation into discrepancies and coordinated correc tive action. ASSOCIATED AIR CENTER, Dallas, TX - Electrical Engineer (Autocad v12/13) 1996 1997 Previous Engineering & Technician Experience at Boeing, McDonnell Douglas, Lear Siegler & Lockheed U.S. AIR FORCE Avionic Instrument System Technician | Non-Commissioned Officer Honorably Discharged