Engineer Control

Name: Dorn Parker

Overview

Twelve (**) years of experience in equipment and system start-

up/commissioning, validation, writing and execution of CQ, IQ OQ and PQ

protocols. Experience in Change Control, Deviation Investigation and CAPA.

Thorough understanding of cGMP's, GAMP and GDP.

Key Skills

. Commissioning and Validation - CQ, IQ, OQ, IOQ, PQ and Final Report

development and execution for CIP (SME), SIP, DCS systems, HMI's,

bioreactors, compressed air, WFI, USP Water Systems, Autoclaves and HVAC.

. Process Automation Validation - Control system & equipment Commissioning,

IQ, OQ. Parameter verification (DeltaV, Allen Bradley), data verification

and boundary testing, alarm and interlock testing.

. Quality Systems - Work with Quality Systems group to align site

procedures with Corporate Quality requirements.

. Change Control - Managed remediation effort to close old paper Change

Control Requests. Performed Quality Review of Change Control Requests and

prepare Change Control documentation for Final QA approval.

. SOP Writing - re-write SOP's and initiate LiveLink Document Change

Requests for SOP's and VMP's to help close Backlog CCRs.

. Deviation/CAPA resolution/Non-conformance investigation - experience

using calibration records, alarm history files, batch records and PI

historian data to investigate equipment failures and protocol deviations

and determine root cause and required corrective actions.

. Autoclaves - experience performing autoclave engineering studies, process

qualifications and data analysis.

. cGMP - experienced with cGMP's, 21 CFR 210 & 211, GAMP 5.

. DeltaV - System Commissioning/ Validation. Troubleshooting running phases

to identify and modify Module level, Phase level, Unit level parameters.

Experience with DeltaV Batch and SME on CIP.

. PI ProcessBooks - Extensive experience in use for troubleshooting during

start-up and commissioning of CIP/SIP systems, monitoring running CIP

phases and recipes, engineering runs, loop tuning, cycle development, non-

conformance investigations.

. RSLogix 5000 - read, troubleshoot and make changes to existing code.

Manipulate control and equipment modules for simulation.

Work Experience

Validation Engineer Oxford Global Resources Sep-12 to Dec-

12

. Managed Validation of non-sterile API spray dryer

. Wrote Functional Requirements and Functional Design Requirements

specifications for spray dryer system.

. Developed IQ/OQ/PQ of USP water tie in to existing USP water system

. Developed IOQ of PLC/SCADA spray dryer control system

. Wrote IOQ protocols for rooftop HVAC units

Validation Engineer (MA) VTI Inc. May-12 to Jul-12

. Wrote and executed IOQ for refrigerator including temperature mapping

. Wrote Final Report for refrigerator IOQ

. Wrote IOQ for Clean Room HVAC unit

Validation Engineer (Genzyme - Framingham, MA) Enterprise System

Partners, Dec-10 to Apr-12

. Work with Quality Systems group to align site procedures with Corporate

Quality requirements.

. Managed remediation effort to close old paper Change Control Requests.

. Perform Quality Review of Change Control Requests and prepare Change

Control Requests for Final QA approval.

. Interface with department leads and managers to provide cGMP guidance for

completing Change Controls.

. Assist Validation as required to review and close open protocols and

deviations

. Investigate and resolve Deviations and Metrology Discrepancy Reports

Validation Engineer (Genzyme - Framingham, MA) Hyde Engineering, Jul-10

to Nov-10

. Operate autoclaves to develop new cycles capable of meeting the

equilibration specifications as stated in EN 285.

. Develop optimized sterilization cycles capable of processing multiple

load configurations.

. Analyze run data and generate technical reports for Validation and

Quality Departments.

. Optimize the current load configurations that may contain items no longer

required for manufacturing operations.

. Execute Process Qualification and Re-Qualifications, analyze data and

write Qualification final reports.

Senior Validation Specialist Commissioning Agents Inc., Dec-05 to Feb-09

GSK Marietta, PA

. Developed commissioning protocols for an RSLogix based process control

system, based on system integrators' functional and design documentation.

. Simulated system operation and analog and digital input modules, alarms

and interlock conditions were simulated and proper response verified on

HMI.

Amgen, Rhode Island

. Authored and executed commissioning protocols for project to provide acid

directly to CIP skids for de-rouging of equipment.

. Performed PID loop tuning for new acid supply flow of new acid and

caustic supply control modules, P&ID and electrical drawing verification

and red-lining.

Amgen, Boulder CO

. Authored and executed validation protocols for ControlLogix based CIP and

SIP systems in multi-product manufacturing.

. Testing included Purification and Fermentation areas, Multi-Product

circuit selection functions, Alarms, Interlocks and Temperature Control.

Lead Validation Engineer Millennium Validation Services, Mar-04

to Oct-05

Amgen, Rhode Island - Bio-Next Project

. Commissioned six-skid DeltaV, CIP system for Amgen's BioNext project.

. Equipment included bio-reactors, media, buffer, harvest and purification

vessels and skids.

. Used DeltaV Operate, DeltaV Control Studio and Delta V Batch to test

control and equipment modules and phases.

. Worked closely with the automation group to diagnose hardware and

software errors and determine corrective actions.

. Used DeltaV and PI applications to perform engineering studies to improve

the operation of the chemical addition operations during wash phases and

perform non conformance investigations.

. Used Batch Records, alarm history files and PI data to perform non-

conformance investigations.

Validation Specialist Bukovac & Duncan TG, Sep-02 to Mar-04

Wyeth, Grange Castle Project, Dublin, Ireland

. Performed Software Factory Acceptance Testing (SFAT) of Emerson Delta V

Control System platform in support of Wyeth facility in Grange Castle

Ireland.

. Reviewed SFAT Test Fault Reports (TFR's), approved corrective actions and

verified faults were correctly retested.

Johnson Matthey, West Deptfod NJ

. Executed commissioning, IQ and OQ protocols using Emerson Delta V

Control, during validation of a bulk pharmaceutical plant.

Validation Specialist (Organon, NJ) Mintanciyan Consulting, Feb-02

to Sep-02

. Functioned as HVAC lead for validation team, validating HVAC system in

new pharmaceutical manufacturing facility.

. Wrote equipment IQ/OQ protocols used to validate the HVAC system and the

associated manufacturing area clean rooms.

Validation Technical Consultant (Aventis Behring, Kankakee, IL) AVS,

Jul-00 to May-01

. Developed and executed HVAC equipment and controls IQ/OQ protocols used

to validate the HVAC system.

. Assisted in updating As Built control drawings using AutoCAD.

Additional Experience

Validation Engineer (Genzyme - Allston, MA) Insight Global Jul-12

to Aug-12

Validation Engineer (Shire HGT - Lexington, MA) Bukovac & Duncan TG

Apr-10 to Jun-10

Manufacturing Support Bristol Myers Squibb, Devens, MA Techsource, Dec-09

to Jan-10

Validation Specialist (Merck, West Point PA) ValSpec May-01 to Sep-01

PLC Technician Centocor, PA 1999 to 2000

Process Engineer US Steel Fairless Works 1997 to 1999

Manufacturing Technician GE Medical (MRI Systems) 1991 to 1993

Senior Technician Marquette Electronics 1983 to 1989

Education

. Studies for Bachelor's Degree Engineering Sciences, Community College of

Philadelphia

. Associates Degree in Electronics Technology, Waukesha County Technical

College

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