Craig Patten
Validation
Specialist / QA
Computer Systems Validation
Validation Verification
& Testing
459 SE Lilly
Ave. #A
Corvallis, OR
97333
Cell (541)
740-0886
craigpatten@hotmail.com
·
Computer System Validation, Verification and Testing
·
IQ/OQ/PQ and User Acceptance
·
Validation Planning, Requirements, Standards,
RBA (Risk Based Assessments)
·
Test plan/suite development (QTP-Validation
Plan)
·
Test scripts/ verification and validation Plans
and Protocols
·
Clinical Database and Laboratory Systems and
equipment validation
·
cGxP (GCP-GLP) / 21 CFR part 11 e-records and
signatures
·
Sarbanes-Oxley (SOX)
SUMMARY
Over ten years of
testing, QA, V&V and CSV experience.
Extensive understanding
of QA as it applies to all phases of the development life cycle, including
design verification, validation and acceptance testing. I am experienced
developing strategic test plans, test cases/protocols and scripts and assuring
that the system requirements are properly specified and have been satisfied,
interfacing with various departments and vendors as required. I have performed
testing products using black box, end-to-end and ad-hoc techniques.
Knowledgeable and skilled in software QA testing: regression testing (both
system and bug), acceptance testing, compatibility testing, system testing,
functional testing, verification and validation, GUI and Internet testing. I
enjoy working with biotech and medical projects, having successfully tested and
qualified class 1 & 2 devices, complying with FDA (CFR) and ISO
regulations. I have experience testing clinical trials database applications
(including Oracle Clinical, ClinTrace / ClinTrial and ARGUS) and pharmaceutical
development and process lab equipment (including chromatography) to 21 CFR part
11, and “GxP” standards (i.e. cGCP, cGLP, etc.) Working with SOPs and
Validation documentation is the focus of my work experience.
WORK EXPERIENCE
Abbott Vascular, Inc.
3200 Lakeside Dr.
Santa Clara, CA.
2/07 – Present: Sr. QA Analyst / Validation
Specialist
As
Part of the Validation team at Abbott Vascular, I wrote the System
Requirements, Validation Requirements, Validation Plans, User Requirements,
Installation and Configuration requirements, Test Plan as well as developing
and testing IQ/OQ/PQ test protocols and reports for Phase Forwards Central
Coding (1.0) and Clintrace (4.1) Clinical Data Management systems.
Medtronic Vascular, Inc.
2440 Research Blvd
Santa Rosa, CA.
9/05 – 9/06: Validation Specialist
As Part of the Validation team at Medtronic Vascular, I
wrote the System Requirements, Validation Requirements, Validation Plans, User
Requirements, Installation and Configuration requirements, Test Plan as well as
developing and testing IQ/OQ/PQ test protocols and reports for equipment and
software systems. Systems included an in-house developed auto-welder and ePCR (Enterprise
Product Comment Reporting System), and purchased systems; OGP Smartscope
inspection system, Dyadem FMEA version 6 and International TechneGroup
Incorporated’s QFDcapture 4.0.11, Thermo-Nicolet FT-IR software (OMNIC), a
corrective and preventative maintenance 'C/APA' program (developed in house) ,Oracle
Clinical, as well as several Clinical Data system data migration projects and
environmental systems (shaker and S/N) custom software validation. Other tasks included contacting vendors and
hosting interdepartmental meetings to provide business usage assessments and recommendations
(Risk Based Assessments).
Otsuka America Pharmaceutical Inc.
2440 Research Blvd
Rockville, MD.
9/04 – 5/05: Validation Specialist
As Part of the Validation team at the Maryland
Research Institute, I wrote the System Requirements, Validation Requirements
and Validation Plan, User Requirements, Installation and Configuration
requirements, Test Plan as well as IQ/OQ/PQ Test Protocols to Otsuka,
"GxP" and CFR 21 part 11 standards. I performed Validation testing
for Phase Forward’s ClinTrace™ and ClinTrial™
drug safety Adverse Reactions database applications. I wrote the validation
plan, validation assessment report and PQ for the in-house automated training
system. I developed validation documents for the Documentum based EPIC document
control system. I also developed gap analysis and remediation documentation
(gap assessments, remediation plans, tests and reports) for several other
miscellaneous clinical data systems, including SAS, WinNonlin, Nonmem, Impact,
DataTrak as well as applications developed in-house. Other tasks included
contacting vendors for vendor assessments, and requirement assessments.
Eli Lilly
1650 Lilly Rd.
Lafayette, IN.
5/03 – 3/04: Validation Specialist
As Part of the Computer System Validation (CSV) team in the
Information Services team, I wrote the System Design and Requirements
validation deliverables for laboratory systems. I performed validation testing
at the Tippecanoe Laboratory site including gap analysis of the IQ/OQ/PQ tests
supplied by / performed by vendors, and wrote qualification documents to fill
any identified gap. I developed CSV validation / qualification documents to
Lilly, "GxP" and CFR 21 part 11 standards.
Genentech
1 DNA Way.
South San Francisco, CA.
10/02 – 2/03: Validation Specialist
As part of the Medical Affairs
Information Technology group I wrote Test Protocols to Genentech,
"GxP" and CFR 21 part 11 standards, including electronic data
transmission methodologies. I performed Validation testing for a drug safety
Adverse Reactions database on the Windows platform, utilizing Oracle 8 and SQL
Plus 3.3, for the ARGUS™ system.
Hewlett-Packard
1000 NE Circle Blvd.
Corvallis, OR.
4/02 – 9/02: Software Quality Engineer
HP
prototype/pre-production notebooks, operating systems, BIOS, drivers and
associated software verification. As part of a test team I tested BIOS versions
and localized HP proprietary Windows XP and 2000 operating systems, peripheral
drivers as well as HP proprietary software. This was primarily a "black
box" testing environment; verifying "shrink-wrapped" software
for US and international (“FIGS”, Hebrew, Greek, Arabic etc.) consumers.
Failures were verified and recorded using a Lotus Notes database.
Comergent
1201 Radio Road
Redwood City, CA.
11/00 - 6/01: Software Quality Engineer
Sell-side
B2B application. I developed test strategies, individual test cases, and
testing plans. Internationalization testing using double-byte character sets,
as well as European languages (e.g. Chinese, Japanese, Cyrillic, French,
German, etc.). Silk was used for test automation. Automated, structured and ad
hoc tests were performed on XML and HTML pages (JAVA). Product functionality as
well as Oracle and Microsoft (SQL) database queries, and auto-mail features
were included in testing. Failures were verified and recorded in bug database,
and were discussed at engineering reviews.
Starlight
205 Ravendale Dr.
Mountain View, CA.
8/00 - 11/00: Software Quality
Engineer
Based on NT/2000 platforms for the
servers, this was a multi-tier streaming media application for the Internet. I
developed test strategies, individual tests, and testing plans. Structured and
ad hoc tests were performed on XML and HTML pages were performed, failures were
verified and recorded in bug database.
IntelliCorp
1975 El Camino Real West, Ste.
201
Mountain View, CA.
8/98 - 7/00: Software Quality Engineer
I
tested business-modeling software for SAP R/3 applications on Windows and
Internet platforms. I developing test strategies, individual tests, and testing
plans. Automated, structured and ad hoc tests were performed; failures were
verified and recorded in bug database. Internationalization/localization
testing using localized Windows platforms (OS and browser) and localized
product versions were performed utilizing double-byte character sets and
"FIGS" languages. Rational test was used for test automation, Load
Runner for load testing. XML and HTML page and Microsoft (SQL) database tests
were included in the testing suite. Failures were verified and recorded in bug
database.
Varian
3075 Hansen Way.
Palo Alto, CA.
6/98 - 8/98: Software Quality Engineer
I
wrote test and validation plans, trace ability matrices, and test
protocols for a motion detection/radiation therapy beam gating oncology
project. I prepared test plans and protocols, performed tests and recorded test
results using electronic and "hard-copy" mediums for FDA submittal;
complying with CFR, FDA and ISO requirements. This product utilized NT as its
platform.
TESystems
1780 Clear Lake Ave.
Milpitas, CA.
11/97 - 2/98: Software Developer
I wrote an approximately 8,000 line
program controlling GPIB devices, a data acquisition card, a vacuum driven
fixture head, and a 10 port "digi" card using National Instruments
CVI ‘C’ programming language. I performed hardware-software integration and ‘on
site’ installation. This project was a "utilitarian" functional test
platform for monitoring device performance parameters while under test
("bed-of-nails", signal generation/monitoring, voltage/current parameters,
etc.) for a production test environment.
Abbott
Diagnostics
5440 Patrick Henry Dr.
Santa Clara, CA.
2/97 - 11/97: Software Quality
Engineer
I performed black box, functional,
and regression testing in the software development group for a hematology
device prototype. I developed functional test cases, attended code reviews, and
did some user interface screen design work to improve usability, including
creating the appropriate flow diagram models. I updated and did some
development work on the software requirements specifications. I wrote test
programs in C and PASCAL. I created and used Microsoft's Access database for
internal problem tracking, analysis, and reports. Device platform was mC
embedded operating system.
Intelliwire
870 Hermosa Dr.
Sunnyvale, CA.
7/96 - 9/96: Software Developer
I
developed control and data acquisition code using Lab View version 4.0 and
BASIC by way of DLLs on the Windows ‘95 platform for angioplasty catheter
development. This project centered on Robotics arm control and thermal profiles
to "blow" the catheter.
Cardiac
Pathways
995 Benecia Ave.
Sunnyvale, CA.
1/94 - 2/95: Software Quality
Engineer
I created several virtual instruments
using National Instruments Lab View version 3.0 graphical programming environments.
These programs acquired analog, digital, and GPIB data. I also performed
verification testing, and hardware-software integration as the SQA
representative. I prepared test procedures and test result data for submission
to the FDA. CFR, ISO, FDA and European standards were complied with. Device
operated in the PSOS embedded operating system platform. Having both a hardware
and software background, I provided QA/Engineering functions from breadboard to
product “roll-out”.
Tandem
Computers / Ungermann-Bass, Inc.
1440 McCarthy Blvd.
Milpitas, CA
5/90 - 7/93: Test Engineer
I built and maintained local area
networks and test stations for the production, test, and repair departments at
the Milpitas
facility. I also performed PC and network software installation and maintenance
for over one hundred stations. I provided QA functions for the software test
department. Technical writing tasks included the re-writing of in-house test
procedure to the ISO 9000 standards, as an ISO team member. I designed and built
test stations and test fixtures in the test-engineering department: documenting
their design, and writing their test procedures.
Bay
area rapid transit (BART)
6/89 - 4/90: Test Engineer
I upgraded the power supplies and
control circuitry used in BART trains. I modified the controller cards
designing and building test and assembly fixtures to facilitate this effort,
performing mechanical and enclosure modifications as well. I assisted QA in the
validation/verification of the upgraded and modified systems.
Aurora Systems
311 Penobscott Dr.
Redwood City, CA.
2/88 - 8/88: Test Engineer
I assisted design engineering by
performing design verification, hardware verification and validation testing,
also performing hardware and firmware modifications. I wrote UNIX shell scripts
to test and debug bit mapped professional video arts graphics stations. I used
the SED, ED and VI editing tools to write those UNIX script programs.
Link
Flight Simulation
1077 East Arques Ave.
Sunnyvale, CA.
9/82 - 4/87: Test Engineer
I administered a UNIX based
twenty-five-node Ethernet network. Administration tasks included: passwords,
login IDs, automating backups, and verifying software revision levels. As TE
Lead, I coordinated task assignments for a crew of eight test engineers. I
provided documentation for the Air Force and Army acceptance test procedures,
and wrote internal test protocols. I held a DOD secret clearance.
Perkin-Elmer
Etec
26460 Corporate Blvd.
Hayward, CA.
2/80 - 9/82: Test Technician
I was responsible for the testing and
debugging of subsystems for an IC master mask writing Electro-Beam Lithography
machine. I wrote ECOs, trouble shooting guides and safety procedures. I also
provided training for technicians and field service engineers on subsystems with
which I had expertise.
Lockheed Missiles and Space
1111 Lockheed Way
Sunnyvale, CA.
9/77 - 12/79: Test Technician
I
tested ICBM subsystems. I was responsible for verification, maintenance and
calibration of ATE systems. I performed system verification testing and
provided test result information to the Navy. I held a DOD secret clearance,
receiving a security commendation.
IVY Tech
State College
7377 Dixie Bee Rd.
Terre Haute, IN.
10/75 - 1/77: Calibration Technician-student
I
maintained and calibrated and verified test equipment for use in the school
laboratory. I built load banks and other fixtures for use in the calibration
lab.
EDUCATION
Almeda State College
10400 W. Overland Rd.
Boise, ID.
5/04
IVY Tech State College
7377 Dixie Bee Rd.
Terre Haute, IN.
6/77
BSCS Almeda
College and AS degree IVY
Tech State College. I have also completed various seminars, in-house training,
self-study programs, as well college study. Studies including network theory,
as well as programming in Lab View, Lab Windows, Basic, Visual Basic, VBA, as
well as C/C++.
CITIZENSHIP
I am a United States citizen.
REFERENCES
Available
upon request