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Rachel Ilsa Tomi Pirkle

Engineering Manager, Sr Level Program & Project Manager, Multi-Disciplined SME, Systems Integrations Specialist, Sr Level Controls Engineering Programmer, SCADA Design, Pharma Systems Design, Medical Devices, QA Technical Writer, CAPA, Change Control, Veeva, Trackwise, Windchill, and Electrical Engineer.

Seeking an opportunity, which will allow continuation of these professional level skills for benefiting a company recognizing the need for the right talent to help obtain the precise goals of maximizing a project profit with on-time deliverables?

Qualifications and Positions of Expertise

Engineering Manager and Multi-Disciplined Pharma Specialist/Agile & MES SME

PLC Controls Engineer/Controls/HMI Engineering /Servers/Networks/IT/BAS-BMS

Systems Integrations Manager/Project Manager/Systems Testing

Process Engineering / Controls / Validations / IQ, OQ, PQ, PPQ, CPV

Six Sigma Consultant/Master Black Belt Professional/Measurement

Compliance, Quality Systems, and Quality Assurance

Statistical Consulting, Quality Engineering, & Mfg. Process Controls

Professional Profile

An accomplished PMP professional with extensive experience in Systems Integration Management, Programming, and installations. Custom Robotic design, Fanuc Robot Cells, & Measurement Flowmeters. Installation/programming, Project Management, Process Control programming, troubleshooting, debugging, testing with relay ladder logic, function block, and structured text. MS Studio programming for C, C++, Visual Basic, and Electrical Engineering. Extensively programming Control Logix, HMI, PanelView Plus, and RSView Studio, AC/DC Drives, system research, designs and installations. Performed Software experience includes Siemens, Rockwell/Allen Bradley/ RSLogix 5/500/5000-Rev 15-20, professional, Toshiba nvTool, PackML, iFix HMI, RSNetWorx, RSLinx, DeviceNet, AS1 safety circuits, GE Fanuc, Transaction Management, and SQL/RSSQL/OPC/ Historian Servers. Utilizing WinCC, ProTool/Pro, FactoryTalk View, Versa View, Panel View, Panel Builder, Step 7 software, for DCS and many other related systems. Cisco VSM configuration programming and installations of Nuclear Power Plant Systems. Midstream Natural Gas Flow Measurement Specialist.

Utilizing Six Sigmaflow Workbench, Minitab and other major Micro Soft S/W for championing black belt mentoring of projects resulting in reaching cost saving goals.

Working well in both individual and team-oriented situations and demonstrated the drive and desire to secure continued success in the future. In utilizing Six Sigma/Lean Manufacturing methodologies, was recognized by peers and superiors as a confident and capable individual who effects the completion of multifaceted projects in a timely and accurate manner. As a mentor, leader and trainer of Engineers, high results were obtained relating to measurable improvements in regard to managed budgets, increased productivity, design improvements, cost savings, customer expectations being met or exceeded and team appreciation along with increased levels of growth of overall company profits.

Areas of Expertise

Management/Leadership Master Black Belt Safety Administration

Lean /Six Sigma PLC Programming Robotic design

BAS, BMS systems Process Flow Controls Conveyors/Motors

Pumps/Valves I/O Elec. /Mech. Assemblies AutoCAD design

Compliance ISO-9004 Engineering Trainer RSBizware/ BizFlow

Measurement Flow Meters RSView SE/ME MS Studio/RS Studio

PC Board design RSWire RTOS, WinNT, XE, 7, 8,10 Agile LMS, LIMS, EDMS

SW/FW/HW System Testing Inspection Vision Systems Fanuc Robot Teaching

MS Office/MS Project Product Design R&D SONET OC48/T1/T3

Ethernet, ControlNet, Profibus C, C++, Visual Basic IEEE, SA, ANSI, CE

PID tuning Digital/ Analog I/O FDA Medical Validation AutoCAD design

Industrial X ray machines 2D/3D Touch Screen HMI Custom PCs/Servers Net IP Systems Designing/R&D Siemens/Allen Bradley/GE Down Link Satellite

Wonderware HMI Cisco VSM Servers Title 21 CFR part 11

IQ, OQ, PQ Validation KEP OPC/Direct logic Oracle/MES/SAP

FactoryTalk Batch Delta V Classes ISA-S88.01 - 022

GE Unicorn 5.31 P&ID Design & Control AC/DC/VFD Drives

SAP / Historian / MES Track Wise Change Control Power BI PMP

PMP Specialist Business Dashboards QA Professional

Professional Summary

TERUMO BCT / Systems Integrations Process Engineering Project Mgr. CO. 3/2022-Present Systems Integrations and Process Engineering Project Mgr. duties of leading teams with equipment specifications, identifying gaps in designs, cGMP, EtO sterilization of medical devices, automation and related projects. Leader and/or assisting in completion of risk documents, CAPA related items, ECN Windchill Change Control, Risk/Benefit Analysis, Health Risk Assessments, VMP, Commissioning, IQ, OQ Validation Protocol Development with executing of the same, along with Automation support.

GSK/Oxford Inc./ Systems Integrations Project Mgr. /IT Network Systems. MO. 08/2021-12/2021 Systems Integrations Project Mgr. Project Engineer Equipment Systems Designs, Cleanroom, BAS-BMS, EMS, Agile and cGMP construction projects. Leader and/or assisting in completion of risk documents, CAPA, Change Control, VEEVA SW, FMEA, Risk/Benefit Analysis, Health Risk Assessments, IQ, OQ PQ Validation Protocol Development with executing of the same, and Automation Programming. New MFG Dust Collection Design, HVAC, and Project management for next generation Equipment. St Louis, Missouri.

Floatin on a Breeze Trucking LLC/ VP Business Operations / Financial Specialist / PM & VP. CO. 08/2020-08/2021

Business Operations daily activities, financial operations specialist for business startup, federal and state regulations requirements.

JABIL/Oxford Inc. / Sr. Level Electrical Engineer / Validation Specialist / PM. N.M 03/2020-08/2020 Project manager, CSV, PQ protocol document creation controls engineering and validation QA testing efforts due to improvement processes and new product codes. Validation quality control measures strictly adhered in compliance FDA, CE and with industry standards. Automation programming RS Studio 5000, RSLogix 5000, RSLogix 500, Agile and Cognex Vision Pro Programming, Procedural Requirements, CSV (Computer Systems Validations), Impact Assessment of Systems and Components on Product Quality.

As a leader and assisting in completion of risk documents FMEA, Risk/Benefit Analysis, Health Risk Assessments, Alarm Lifecycle Management, and Validation Procedure Qualifications. Project Manager for multiple equipment lines for packaging, sterilization for medical devices from Johnson & Johnson (J&J).

GSK/Oxford Inc./ Systems Integrations Project Mgr. /IT Network Systems. N.Y. 03/2017-01/2020 Systems Integrations Project Mgr. / Engineer with updated PMP certificate training. Cisco SW, Dell Servers, Oracle Database, Network System configurations, IT Systems Designs, Cleanroom, BAS-BMS, IT Control Room construction, SQL-2016, MS Server 2016, firewalls, MERP/SA, Automation FactoryTalk/ControlLogix systems, CQS Validations, cGMP, over $589K savings. Leader and/or assisting in completion of risk documents FMEA, Risk/Benefit Analysis, Health Risk Assessments, IQ, OQ PQ Validation Protocol Development with executing of the same, and Automation Programming. New MFG PreMix Vessel Project management for next generation Equipment. East Durham, NY.

Corning Inc./Noramtec Inc./Sr. PAC/PLC Engineer/Project Manager. Corning, NY 01/2016-03/2017

Catalytic Products MFG, Process Controls Engineering, Electrical Controls, PMP, Project Management, SW Design & Development, Ethernet, Modbus Networks Systems. ControlLogix, RSView SCADA. Software Design Documentation with ISA S88.01 PackML Compliances for batch Processes and Vision Inspection. FAT/SAT, Commissioning, Protocols Design, PLC programming, along with and I&E Support for IOQ, PPQ, & CAPA processes.

ALCON Inc./Oxford/Sr. Process Engineer/Project Manager. Ft. Worth, TX. 05/2015-09/2015

Medical Products MFG, Project Management role, Process Controls Engineering, Electrical Controls, P&ID AutoCAD design, Ethernet, Modbus Networks Systems. ControlLogix, iFix SCADA. Leader and/or assisting in completion of risk documents FMEA, Risk/Benefit Analysis, Health Risk Assessments.

Software Design Documentation with ISA S88.01 CFR12 Compliances for batch Processes. FAT/SAT Protocols Design, PLC programming, along with and I&E Support for IOQ processes.

Enable Midstream Partners/OG&E/ Sr. Controls Engineer. OKC, OK 10/2014-04/2015

Electrical Controls, Power & Network Panel AutoCAD design of DWGS, Fiber Networks, Ethernet, and Modbus design with ESD Systems. ControlLogix, Power Flex, AIFM Modules, MCC Intellicenter, Wonderware HMI SCADA. Design, programming, along with Project Management role and I&E Support.

KTH/Honda/Oxford/Project Manager. Leesburg, AL 05/2014-10/2014

16 new Robot Cells, 48 Fanuc robot’s installation of new projects, and relocation of existing robots along with managing vendors, budget controls/project timelines all accomplished on-time and under budget. RIA R15.06 regulations compliances maintained with all scope of project.

Alexion/Rovisys/Oxford/Sr. Controls Engineer Lead. Rhode Island 02/2014-05/2014

Systems Automation Configuration, RSView HMI programming, FactoryTalk Batch programming, ISA-S88.01, RSLogix programming for batch Process Cell, Units, Equipment Modules, and Control Strategies. Pharmaceutical batch processes validation CFR21 part 11 compliances. AC/DC Drives programming, and configurations file management. Leader and/or assisting in completion of risk documents FMEA, Risk/Benefit Analysis, Health Risk Assessments

Evraz/Oxford Inc. / Sr. Systems Controls Engineer. Portland, OR 08/2013-02/2014

Siemens PLC, WinCC, HMI, SCADA, SQL. L1 & L2 programming of process control for Steel Rolling Mill, pipe for Oil and Natural Gas Systems. Helped with site updates, process validations, programming changes, SW updates and troubleshooting. With direct impact improvements, production increased ~70% resulting in over $490,000 per month.

Shire/NNE/Oxford Inc. / Sr. Technical Writer 07/2013-08/2013

Policy and SOP’s document creation and updates for impacting mitigation efforts due to improvement needs and concerns. Validation quality control measures strictly adhered in compliance with industry standards. Automation Procedural Requirements, VCS (Validation of Computer Systems), Impact Assessment of Systems and Components on Product Quality, Leader and/or assisting in completion of risk documents FMEA, Risk/Benefit Analysis, Health Risk Assessments, Electronic Records Signature Policy, Alarm Lifecycle Management, and Validation Test Bed.

TEMIC/Oxford Inc. / Sr. Systems Controls Engineer 02/12-04/2013

Systems Controls, DCS Engineering and HMI Programming. Toshiba vTool Military Grade VME Buss PLC and iFix HMI systems engineering for Hot & Cold Mill Steel & Aluminum Industry. Systems for India, Italy, China and USA. Validation quality control measures strictly adhered in compliance with industry standards.

Rockwell Automation/Oxford Inc. / Sr. Systems Test Engineer 02/2011-06/2011

Systems Test Engineer/Systems Programming. Rockwell AC/DC Drives and PLC Firmware, and HW testing along with Version 20 ControlLogix SW testing, Network System configurations. Python Code Programming, Systems configurations applications. Mequon, Wisconsin

Arinc Inc./Oxford Inc./ Systems Integrations Mgr. /Nuclear Power Sys. 10/2009-05/2010

Systems Integrations Project Mgr/Engineer. Cisco Server, Oracle Database, Network System configurations, motion detection systems, IR digital Cameras, workstation setups and lockdowns, firewalls, and digital encoders for weapons systems. PA and Maryland.

Ethicon/J&J/Oxford Inc. / Sr. Controls Engineer/FDA, Validations 04/2009-07/2009

Controls Engineering and FDA Validations support. Lean process programming and

Validation of medical equipment. Juarez Mexico.

Energy Recovery Inc. / Think Resources/Sr. Controls Engineer Contract Oklahoma 02/ 2009-07/ 2009

Allen Bradley PLC, HMI, SCADA programming for process fuel from extracted sources.

Helped with site shutdown and process validations.

DC/AC Drives programming and troubleshooting.

Zimmer / Oxford International/R&D Systems Integrations Mgr. NJ. 04/2008-09/2008

Designer of new machinery and new Process Control Systems. PLC, HMI, SCADA, Agile, Robotics Design and Installation, Procurement, programming, Title 21 CFR Part 11 Validation, Leader and/or assisting in completion of risk documents FMEA, Risk/Benefit Analysis, Health Risk Assessments, and Management of project. Six Sigma Mentor/Black belt trainer.

Prime Electrical Inc/VP of Operations/Project Manager. OKC, OK 10/2007-02/2008

Developer and PMP manager processes for management for Six Sigma Methodologies for business operations and for budgets of all Projects. Managed large projects totaling over $6 million dollars. All projects are on time and under budget as planned with at least 27% profit margins. Installed and managed all IT Department solutions and purchases.

Managed other managers, foreman and office Personnel on several projects.

System Integration Manager/Controls Eng. Corning/Oxford NY/Taiwan 08/2005-09/2007

Developed Process improvements, managed installation of machines setup and operation. Managed outside vendor’s setup and troubleshooting of machine problems or S/W issues which required programming changes. Also, a Specialist of Vision equipment for microscopic measurement of glass utilized for flat screen computer monitors and TV display. Assisted in new design and trained other Engineers in classroom settings and one on one session. My travel was 80%-90% USA and Overseas. Utilization of MS Studio programming of RSView SE/ME, VB, C++ and other tools to assist in programming changes or troubleshooting for suggesting or making improvements. Lead Power Point presentations, Excel preparations and data tracking along with procurement processes. Allen Bradley PLC/HMI Operations, Device net, Ethernet and Protocol troubleshooting. Succeeded in training others in Six Sigma methodologies and projects. PMP training and implementation with other PM’s.

Systems Integrations Engineer, Womack Electric/Automation, OKC, Oklahoma

Electrical Project Manager/Electrical Foreman 10/2000-01/2005

Education

TMEIC Industrial VME Bus Innovation Control HW and Toolbox SW programming. Toshiba VME Bus Controller 64 bit HW and VTool.

Precision instrument HW & SW Training 2012-2013

Professional Rockwell Systems Testing of Firmware/ControlLogix SW Version 20 Custom Training. Python Programming Training 2011-2011

Six Sigma Deployment Exec., Champion, Master Black Belt 1999-2007

(Waiting for final testing of completion)

Journeyman Electrical License. Oklahoma (current) 1980-2019

Kennedy Western University BSEE/CS/5credits remain 2002-2006

Master Electrical License. State of Colorado. 1989-2000

BSEE/CS. Hillsdale College and Texas Instruments 1977-1983

Professional Degree. NASA Satellite Communications 1980-1981

Rose State College. National Electrical Code Classes 2006-2006

Note: Professional and Personal References upon request.

Professional History Summary

Over Seventeen years of combined Compliance, Quality Systems, and Quality Assurance experience related to FDA cGMP’s, Part 820, Parts 210/211, GLP’s, Part 11, ISO 13485, & ISO 14971. This includes compliance, gap analysis, FDA/ISO Audits, Design Controls and Design Transfer, Post-Market Surveillance (Complaints), CAPA, Manufacturing Quality/Process Control, Deviations, Change Control, Quality Engineering, Corrections & Removals, Risk Management, Supplier Quality, Training, and Quality Planning.

Over ten years of progressively responsible experience in Quality Management. Senior level experience (responsible for managing quality managers & supervisors) is included along with coordinating QA programs as well as experience with multi-plants and international (Taiwan).

Over twelve years of experience in Continuous Improvement, Engineering Management & Project Management in mfg., and service including Six Sigma methodologies, Lean Quality Systems (Transactional Processes), Lean Mfg., Total Quality Management (TQM). Project management experience for data-driven and systematic approach to problem solving with a focus on customer impact, having completed over seven each Six Sigma related projects. This includes using value stream mapping, 5s, visual control, Kaizen events, optimizing flow, proven statistical methods, risk management, and standardization.

Over fifteen years of experience in Statistical Consulting, Quality Engineering, & Mfg. Process Controls including problem solving, risks management, process evaluations, documenting statistical rational and continuous improvement. I am proficient in the areas of advanced statistical techniques, SPC, risk analysis, acceptance sampling, process capability, regression analysis, experimental design (DOE & ANOVA), and product audits. Quality system support core competencies include R & D QA (Design Controls, Design Validation, Supplier Evaluation, Product Testing & Clinical); Mfg. QA (Design Transfer, QC Inspection, Purchasing Controls & Incoming Inspect.); Process Controls (Validation, Measurement System Analysis (MSA), Gage R & R, Automated Systems Validation); and Quality Systems (Auditing, CAPA, & Mgmt. Review).

Over fifteen years of experience in Process Validation (IQ, OQ, PQ, PPQ & CPV) including medical device and pharmaceutical industries, and including validation execution, developing policies and procedures, validation project mgmt., risk mgmt., master validation plans, validation sampling plans, confidence levels, developing validation requirements and protocols, equivalence and qualification (i.e., Facility, utilities, mfg. processes, equipment, automated processes, vision systems, sterilization, cleaning, packaging, test methods, environmental monitoring, etc.), and Continued Process Verification (CPV) process development and implementation.

Over twenty years of experience in Computer/Software Verification & Validation including lifecycle & QA system development, GAMP, design controls, risk mgmt., laboratory information systems, networked based systems, software products for patient monitoring, mfg. requirements planning (MRP) systems, enterprise resource planning (ERP) systems, SAP, electronic device history record, mfg. shop floor data collection systems, object oriented programs, databases, electronic records & signatures, testing, & requirements definition for software, hardware & firmware. This includes technical writing for procedures, protocols, reports, test cases, traceability matrices, and user documentation, and validation execution.

Over ten years of experience in Risk Management including oversight of compliance related activities and deliverables for product development for medical devices and software. This includes Hazards and Harms development, DFMEA development, and PFMEA development. Additional experience includes Health Hazard Evaluations (HHE). Leader and/or assisting in completion of risk documents FMEA, Risk/Benefit Analysis, Health Risk Assessments

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