SON VIET

Phone: Mobile: 408-***-****

Email: abna5z@r.postjobfree.com

SUMMARY OF EXPERIENCE:

Experience in the Medical Device, Biotech and Pharmaceutical industries.

Experience includes Validation, Quality Control and Quality Assurance.

Performed validation development, execution and review of validation

IQ/OQ/PQ protocol and data acquisition.

Data logging and archiving.

Alarm handling.

Access control mechanism.

Human Machine Interface including many standard features e.g. alarm

display, trending.

Knowledge of cGMP concepts in FDA-regulated industries

Skilled in development of Preventive Maintenance and Manufacturing SOPs

Strong investigative, problem resolution and organizational skills

Windows XP, Microsoft Office Suite, Kaye Software

Experience:

Abbott Hematology

5440 Patrick Henry Dr. Santa Clara, CA 94003

Nov 2009 to Present

Position: Validation Consultant

Review SOP and Procedures and quality process equipment.

Developed test scripts for Autoclave (Characterization Study/IQ/OQ/PQ)

protocol for execution. Performed corrective actions for deviations during

execution for turnover package approval.

Abbott Vascular

400 Saginaw Dr. Redwood City, CA 94003

Nov 2008 to Jun 2009

Position: Validation Consultant

Test Methods Validation on Suture Medical Devices. Evaluating Medical

Device design to create product equipment builds for testing to incorporate

into protocols for Gauge R & R studies.

Working closely with System Owners on developing production design

specification and scoping for equipment build.

Perform gap analysis on process for validation.

SOP development on procedures and quality process equipment.

Developed test scripts (IQ/OQ/PQ) protocol for execution. Performed

corrective actions for deviations during execution for turnover package

approval.

Avail Pharmaceuticals (Boston Scientific)

7700 Bent Branch Dr., suite 100, Irving, TX 75063

March 2008 to Aug 2008

Position: Validation Consultant

Managing process for Mach 1 and Wiseguide catheter lines.

Review DHR forms and Inspection qualifications during Mach 1 and Wiseguide

Inspections prior to and after inspection.

Performed gap analysis for Mach 1 and Wiseguide inspection.

MRI Network, Management Recruiters, Salt Lake City, UT

GE Healthcare, Salt Lake City, UT

June 2007 to October 2007

Position: Validation Consultant

Assisted in the development of quality procedures to be implemented into a

control system for the Validation Remediation Project.

Generated (IQ) Installation Qualification of Biomedical Devices (System

Test Towers, Test Power Meters and Sensors).

Generated Test Methods Validations for verification of processes of

Biomedical Devices (System Test Towers and PCB Boards) for Validation

Remediation Project.

Pharmtech Inc, Libertyville, IL

Boston Scientific,Maple Grove, MN

1 Scimed PI, Osseo, MN

March 2007 to April 2007

Position: Validation Consultant

Create and update documents per product data management (PDM).

SQL software query's for OQP qualification on Line G Peripheral Marker Band

Crimper.

Recipe Manager for product recipes on Line G equipment qualification.

Boston Scientific, Spencer, IN

780 Brookside Dr., Spencer, IN 47460

September 2006 to March 2007

Position: Validation Consultant

IQP protocols development for manufacturing/extrusion equipment in a

medical device environment (PVR project). Development of test plans, test

procedures and component specifications.

Reviewed and Updated (SOPs, Drawings, Preventative Maintenance Procedures)

for submittal into PDM.

Test Scripts including IS, digital electronics, Manufacturer's standard

supplied software, custom integrated systems firmware and PLC logic systems

Pharmaceutical Validation Solutions, Middleburg, PA

Shire

700 Main St., Cambridge, MA 02139

June 2006 to September 2006

Position: Validation Consultant

Responsible for writing and executing IOQ protocols for change controls on

CIP, CA, WFI and CHWS systems for manufacturing environment.

Developed and Executed on Systems Controls and Data Acquisitions (SCADA)

Systems within a manufacturing environment.

Validation Consultant, GTKS, Puerto Rico

Novartis, Vacaville, Ca

February 2006 to April 2006

Involved in generating, developing of IQ/OQ/PQ protocols for fermentation

and cell culture population. Processing equipment includes coldrooms,

bioreactors and process air.

Assisted in developing and executing commissioning documentation for

engineering turnover packages (ETOP).

Sr. Validation Consultant, IT&E international, Solana Beach, CA

Boston Scientific, 1 Scimed PI, Osseo, MN

October 2005 to January 2006

Responsible for writing and executing IQ/OQ/PQ protocols for

manufacturing/extrusion equipment in a medical device environment.

Assigned to develop test plans, test procedures, and component

specifications. Execute approved plans and prepare final reports for

extruders, injection-molding machines, resin blenders & weighing systems,

including PLC control systems. Other equipment includes extruders,

braiding machines, and custom stent manufacturing equipment.

VaxGen Biopharmaceuticals, South San Francisco, CA

July2004 - October 2004

Developed and executed Installation/Operation & Performance Qualification

(IQ, OQ, PQ) for Anthrax and Immunoassay at VaxGen Laboratory. Processing

equipment includes Precision Microplate Reader, Freezers, Cryo Systems and

Incubators.

Developed, SOPs and Preventive Maintenance Procedures.

Validation Consultant, COMPLI, LLC; PA

Eli Lilly Pharmaceuticals, Indianapolis, IN

October 2003 - July 2004

Developed ETOP turnover packages for manufacturing equipment and developed

and executed IQ/OQ Qualification for lyophilizers.

Glaxo-SmithKline Pharmaceuticals, Conshohocken, PA

July 2003 -Ocober2003

Developed and executed Installation/Operation Qualification (IQ, OQ) for

manufacturing facility.

Processing equipment includes Flow Hood, Incubator, Freezer and oven.

Packaging equipment including Labeler.

Validation Consultant, Washington Group International, Princeton NJ

Alkermes, Boston, MA

February 2003- July2003

Developed and executed Installation/Operation Qualification (IQ, OQ) for

R&D facility, Equipment included Air Handler Unit.

Validation Specialist II, Stelex-TVG Inc.; Conshohocken, PA

University of Iowa Research Institute, Cedar Rapids, IA

December 2002-February 2003

Developed and executed Installation/Operation Qualification (IQ, OQ) for

Wyeth and Iowa University R&D facility.

IVAX Pharmaceuticals,

Sommerset, NJ 08873

October 2002 - December 2002

Developed and executed Installation/Operation (IQ, OQ) for R&D and tablet

manufacturing facility.

Processing equipment includes Kilian Tablet Presses, Accela Coaters and

Fitzmill.

Monsanto, Augusta, GA

September 2002 - October 2002

Performed Installation/Operational qualification protocols (IQ, OQ and PQ)

protocols to support Facility Validation Services Project manufacturing

equipment.

Developed and executed protocol for utility and processing equipment

including nitrogen distribution system and compounding tank.

Pharmacia UpJohn Corporation, Kalamazoo, MI

July 2001 - September 2002

Performed Installation/Operational qualification protocols (IQ, OQ and PQ)

protocols to support Facility Validation Services Project manufacturing

equipment.

Developed and executed protocol for utility and processing equipment

including nitrogen distribution system and compounding tank.

Environmental monitoring CIP systems. Swab testing

Schering-Plough Corporation, Kenilworth, NJ

April 2001 - July 2001

Performed Installation/Operational qualification protocols (IQ, OQ) on new

and existing laboratory equipment.

Responsible for developed and executed validation Installation/Operational

qualification protocols (IQ, OQ), as well as the revalidation of

manufacturing and processing equipment in accordance with current industry

standard practices cGMP requirements, regulations, and guidelines

associated with the production of solid dosage tablet manufacturing.

Developed and executed protocols for various types of equipment including

dryers, HVAC, ovens, tanks, blender, and mixers. Performed temperature

thermo-mapping utilizing the Kaye Valuator 2000 on dryer and oven.

Aventis Pasteur (Pasteur Merieux Connaught), Swiftwater, PA

April 2000-April 2001

Reviewed and redlined protocols, obtained necessary information from

vendors, developed and executed Installation/Operational and Performance

qualification protocols (IQ, OQ, PQ).

Developed and executed protocol IQ/OQ of HVAC and Certification of 10,000

sq/ft Warehouse for GMP Storage.

Revalidation of manufacturing, process, and laboratory systems/instruments

associated with the production of biological vaccines.

Worked on various types of equipment including: Biosafety cabinets, laminar

flow hoods, mixing and holding tank, refrigerator, walk-in and chest

freezer, incubator, filter housing, pump, sonicator, centrifuge, scale, CIP

system, bottle washer, autoclave, utilities.

Experience performing swabs and weekly Listeria testing and ATP monitoring.

EDUCATION: BA, Temple University

Other Course & Training

(2005) VaxGen GxP training course

(2005) VaxGen Training on Change Control, Deviation Procedures and Quality

Systems.

(2005) IT&E course for Kaye Validator 2000

(2004) IT&E course for Kaye Validator 2000

(2004) IT&E course for cGMP 210/211

(2004) IT&E course for Medial Devices regulated by FDA 820

(2001) Corporate cGMP refresher course

(2000) Corporate Kaye Validator 2000

TEST EQUIPMENT:

Kaye Validator 2000 Kaye Digistrip 4Splus Multimeter

Tem Tips

Tachometer UV Inspection Equipment Dragger Tube Air

Sampling Equipment

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