Engineer Plant

JOSEPH T. WARKOCZEWSKI RESUME

* ******** ****

Greenville, SC 29615

Telephone/Fax: 864-***-****

E-mail: ******@*********.***

EDUCATION:

Master of Science, Mechanical Engineering, The University of Kansas.

Bachelor of Science, Mechanical Engineering, The University of Kansas.

VALIDATION EXPERIENCE:

. Saint Jude Medical, Minnetonka, MN 1/2010

to 04/2010

Employed by RCM Technologies as a Contract Validation Engineer

Wrote IQ, OQ, Equipment Specifications, Software and Risk Assessments,

executed IQ and OQ and wrote Final Reports to qualify medical device

equipment and fixtures. Equipment included Auto Mandrel Puller, Auto Wire

Pull, Auto Window Cutter and various fixtures for catheters. Worked with

Windchill electronic record system.

. Pfizer (Wyeth) Pharmaceuticals, Pearl River, NY

1/2008 to 12/2009

Employed by Beepix, LLC as a Contract Validation Engineer / Specialist.

Building 250 Vial Line - Was assigned to assume the duties of a Validation

Specialist who left suddenly. Successfully completed remedial

qualification work for large bottle vial line. Wrote reports for WFI and

Compressed Air IOQ. Wrote IOQ protocol, executed and wrote report for

reclassified GMP laboratory. Wrote Compressed Air Development Study,

executed and wrote report. Wrote Compressed Air PQ, USP Purified Water IOQ

and Environmental IOQ for Vial Filling Suite.

Building 100, Vial Line - Support validation qualification of the New

Aseptic Vial Filling Line. Execute Process Validation protocols and write

reports for aseptic vial filling line. Co-ordinate outside Container

Closure Integrity tests. Write and execute IQ and IOQ protocols and

reports for: Class B Pass-Thru, TME Pressure Leak Tester, Tubing Fuser and

GPS Synchronized Digital Clocks. Execute and write reports for Development

Studies and Performance Qualifications of aseptic vial washer and aseptic

capper. Execute PQ Environmental Monitoring of Aseptic Vial Filling

Production Area as team member using RODAC & Settling Plates, Met One and

SAS.

. Alexion Pharmaceuticals, Inc., Smithfield, RI. 6/2007 to

11/2007

Employed by Hitachi America, Ltd., Validation Services Group as a Contract

Validation Specialist.

Execute IQ protocols and write reports for a manufacturing POD filter

system, Harvest Vessel, CIP skids with distribution systems and IQ and OQ

for a QC autoclave. Assisted the validation team in execution of air

handling unit IQ protocols and Buffer Hold Vessel OQ protocols.

Boston Scientific, Spencer, IN 1/2007 to

3/2007

Employed by Validant Consulting as a Contract Validation Engineer.

Perform assigned team tasks to validate a multiplicity of plastic tubes

made by extruding machines.

. Boston Scientific, Maple Grove, MN 7/2006 to 1/2007

Employed by IT&E International as a Contract Validation Engineer.

Write and execute IQ Protocols, prepare IQ Reports, ERS, ETF and other

documents for manufacturing equipment and tools to make medical

intervention devices. Preparation and execution of IQ Protocols/Reports

for mandrels, skivers, trimmers, slitters, heat guns, timers, vacuums,

ovens, etching, gage pins and sealers. Work with Global Product Document

Management system.

ImClone Systems, Inc., Branchburg, NJ. 10/2005 to

5/2006

Employed by Hitachi America, Ltd., Validation Services Group as a Contract

Validation Specialist.

Resolve IQ/OQ discrepancies for bioreactors (small, medium & large), bulk

fill bags, media prep tanks, buffer hold tanks, WFI and execute PQ

protocols for bioreactors and process equipment. Review protocols for

autoclave development studies and OQs.

JOSEPH T. WARKOCZEWSKI (Cont'd) Page 2

Wyeth Vaccines, Pearl River, NY. 10/2001 to

9/2005

Employed by Synerfac TS and Validation Masters, Inc. as a Contract

Validation Specialist.

o Write and execute IQ, OQ & PQ protocols for pharmaceutical

laboratory equipment and utility systems.

Development and execution of IQ/OQ/PQ validation protocols and reports for:

Ultrasonic Cleaner, Genesis Alarm System (used for monitoring and paging

plant utilities e.g. WFI, HVAC, air compressors, etc.), Biological

Safety Cabinets, Near Infrared Spectrophotometer, Sterile Tubing Welders,

Clean In Place System,

o Validator 2000 temperature mapping of Autoclaves, Water Baths,

Chill Rooms, Incubators, Refrigerators, Freezers;

o Environmental testing (using laser particle counter, STA, RODAC

plates and settling plates);

Received 80 hrs. SOP and Safety Training, Review of Engineering Turn Over

Packages (ETOPs);

o Some validation included 21 CFR 11 requirements for computer

validation; Risk Analysis, User Requirement Specifications and

Validation Plan.

. Barry-Wehmiller Design Group, Inc., Duncan, SC. 6/2001

to 9/2001

Employed by Aerotek, Inc. as a Contract Validation Engineer to prepare IQ &

OQ protocols and Functional Specifications for high speed, computer-

controlled pharmaceutical packaging equipment.

Pitman-Moore, Terra Haute, Indiana (4/1991 to

1/1992)

Employed by Valigen, Inc., div. Bishop Technology, Inc. as a Validation

Engineer to execute IQ and OQ protocols.

Incubators, Plant Steam System, Clean Steam System, Chilled Glycol System,

Chilled Water System, Emergency Generator System, Microbial Control System,

Deionized Water System, Deionized Water Storage and Distribution, Low

Pyrogen Water System.

GENERAL ENGINEERING AND CONSULTING EXPERIENCE:

Registered Professional Engineer in the States of Kansas, Colorado and

South Carolina.

Technical Consultant, Self-employed, Greenville, SC.

1998 - 2001

Arizona Insulation, Inc., Casa Grande, AZ. Employed by Thermal Design,

Inc. as a consultant to prepare a detailed report about reopening a closed

mineral wool insulation plant.

. Gulf Glass Fiber Technological Industries Co. Ltd (Fibertech).

Completed a 10-month project, in Saudi Arabia, to design, construct

and erect a large industrial oven to dry fiber glass roving.

Performed all engineering and project management tasks personally

. QuietFlex Mfg. Company, L.P. Process consulting at Houston, TX plant.

. PPG Industries, Inc. Process consulting at Shelby, SC plant.

. World Advanced Technology, Inc. Process consulting at OCF, Newark, OH

plant.

. Fibertech. Worked two 3-month tours in Saudi Arabia. Converted the

main fiber drying ovens to electric heat and completed other plant

process projects.

Process & Environmental Engineer, Bishop Technology, Inc., Greenville, SC.

1993-97

Designed mechanical process equipment for an 8000 MT/YR. continuous

filament glass fiber plant in Saudi Arabia. Was Site Manager, living in

Saudi Arabia, for installation of all process equipment. Assisted the

plant in the start-up and stayed to help improve plant performance.

Technical Consultant, Self-employed, Denver, CO. 1980-

92

-Reviewed spinner manufacturing process for Cape Insulation at

Washington, England.

-Designed centrifugal glass fiber generator and spinner for T.B.A. -

Bishop, Ltd.

-Installed finishing equipment for continuous filament fiberglass plant

in Polotsk, Russia.

-Reviewed process and plant operation for Roxul mineral wool insulation

plant in Canada.

-Assisted in contract negotiations for mineral wool insulation plants

while in Beijing, China.

-Served as expert witness in patent lawsuit, Johns Manville v. Guardian

Insulation.

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