OBJECTIVE
Assist organizations with technical writing, web development, ISO 9000
and engineering challenges.
PERSONAL INFORMATION
·Technical Writer/Editor - Website Developer - ISO 9000
Consultant - Engineer - Trainer - Author
·HTML Writers Guild - Macintosh and Windows DeskTop
Publishing (DTP), Systems Owner
·Senior Member: Instrument Society of
America
(ISA), ISA General Board of Review
·ISA Scientific Instrumentation & Research Division, ISA
Aerospace Industries Division
·Member: American Institute of Aeronautics and Astronautics
(AIAA)
·Author of: Conversion Factors for Scientists, Engineers
and Students (Prentice-Hall)
SUMMARY
Experience includes over twenty-five years as a technical writer in
operations, maintenance, engineering and R&D environments. Work
experience includes; statistical methodology, trend analysis, computer
hardware, software, integrated circuit, internet, electric, electronic
and mechanical components, standards and systems. Knowledge of 21 CFR
Part 11, ANS, ANSI, ASME, CAPA, CFR, cGMP, CMM, DOD, DOE, FDA, GLP,
HTML, IEEE, INPO, ISA, ISO, MIL, NQA-1, NRC, QSR, SDLC and SEI
requirements, etc. Experienced technical writer/editor, website
developer, ISO 9000 specialist, engineer, trainer and author. Aerospace,
manufacturing, government, nuclear, pharmaceutical, refinery, utility,
educational institution, commercial and industrial positions worked on
both a contract and direct basis. Specialized in short to medium-term
projects.
COMPUTER SKILLS DOS, Mac OS, Microsoft Windows 3.1, Windows 95, Windows 98, Windows
2000, Windows NT, UNIX, Microsoft FrontPage, HotDog Pro, HotMetal Pro,
HTML, WebTools Deluxe, Active Server Pages (ASP), CGI, JavaDoc,
JavaScript, Documentum, PVCS, SourceSafe, Visual SourceSafe, Microsoft
Office Suite (Word, Access, Excel, Outlook, PhotoDraw, PowerPoint and
Publisher), Microsoft Project, WordPerfect Office Suite (WordPerfect,
Quattro Pro, Corel Presentations, Corel Print Office, Paradox 9 and
NetPerfect), Lotus Notes, FreeHand, Illustrator, PaintShop Pro, Adobe
Acrobat, Exchange, FrameMaker, PhotoShop and PhotoDeluxe, Microsoft
Internet Explorer and NetMeeting, CU-SeeMe, Netscape Communicator and
Navigator, ClipMate, HiJack, Thumbs Plus, Norton SystemWorks and
Utilities, Rational Rose, Crystal Reports, StarFish Utilities, Copernic,
DataGrabber, Inforarian Quest, Mata Hari, SpySuite, Research Pro and
WebFerret Suite, etc.
ABILITIES
·Ability to supervise personnel and get along very well
with others, even in difficult situations
·Ability to operate a wide variety of computer platforms
using a broad spectrum of software
·Ability to successfully design and implement various types
of documentation and systems
·Ability to draw on vast experiences to produce
cost-effective, quality solutions to client needs
ACHIEVEMENTS
·Worked various positions with some of the most prestigious
organizations in the country
·DOE Conduct of Operations (CONOPS), Outstanding National
Achievement Award
·DOE Significant Achievement Award for work on Annunciator
Response Procedures (ARPs)
·Author of Conversion Factors for Scientists, Engineers and
Students (Prentice-Hall)
HISTORY
PROJECT
TITLE
TASK
Wyeth (Pharmaceuticals),
Worldwide Headquarters, Collegeville ,
PA(02/05 - Present - Telecommute)
SENIOR TECHNICAL WRITING AND BUSINESS PROCESS CONSULTANT Developed the Wyeth Worldwide Environmental Health and
Safety (EHS) Policies Manual, including; Wyeth Corporate EHS Policy, for
Robert Essner, President and Chief Executive Officer (CEO), Management
Systems, Accident Investigation and Reporting, Regulatory Inspections,
Safe Work Practices, Capital Projects, Operational Readiness Reviews (ORRs),
Personnel Protective Equipment (PPE), Ergonomics, Process Safety
Management (PSM), Contractor Management, Lab Safety, Change Management,
Machine Guarding, Hazard Communication, Respiratory Protection Program (RPP),
Hazardous Substances, Confined Space Entry and Lockout/Tagout, etc.
PROJECT
TITLE
TASK
BostonScientific Electrophysiology (Medical
Devices), San Jose
, CA (03/05 - 07/05)
SENIOR TECHNICAL WRITING CONSULTANT Assisted production supervisors,
engineers and managers with the preparation of Master Validation Plans
(MVPs), Manufacturing Process Instructions (MPIs), Work Instructions (WIs),
Validation Protocols, databases and spreadsheets for various product
lines including; Blazer II Cardiac Ablation Catheters, Chilli Cooled
Ablation Catheters, Explorer Fixed Curve and Rotational Diagnostic
Catheters, Polaris Steerable Diagnostic Catheters and RPM Realtime
Position Management Catheters, to comply with the appropriate FDA
requirements including 21 CFR Part 11, etc.
PROJECT
TITLE
TASK
Bristol-Myers
Squibb (Pharmaceuticals),
Global Shared Services, Information
Security and Service Assurance - Quality Assurance, Princeton ,
NJ(09/04 - 01/05)
SENIOR TECHNICAL EDITOR, INFORMATION SECURITY
QUALITY ASSURANCE Assisted analysts, architects,
developers, engineers and managers with 21 CFR Part 11 and
Sarbanes-Oxley Act (SOX) requirements compliance for validated computer
systems, and validated manufacturing systems, etc. Developed and used
templates, procedures and SDLC documents including Basis of Estimates,
Scopes of Work, Project Plans, Design Documents, Software and Hardware
Specifications, Test Scripts, Project Summary Reports and Records
Retention Requirements, etc.
PROJECT
TITLE
TASK
Pfizer Global Research and Development (PGRD)
(Pharmaceuticals), FDA Validated Computer System Migrations,Groton ,
CT
(01/04 - 06/04) SENIOR TECHNICAL WRITER
Assisted management, architects and developers in
the migration of FDA validated computer systems. Developed and used
templates, procedures and SDLC documents including Basis of Estimates,
Scopes of Work, Project Plans, Design Documents, Software and Hardware
Specifications, Test Scripts and Project Summary Reports etc., to comply
with SAIC, PGRD and 21 CFR Part 11 requirements, etc.
PROJECT
TITLE
TASK
Roche Diagnostics Corporation (Medical Devices and
Pharmaceuticals), Single Strip System Glucose Meter,Huntsville ,
AL and
Indianapolis ,
IN
(06/03 - 01/04) SENIOR TECHNICAL WRITER
Assisted in the development of the rack and
test-fixture Automated Test Equipment (ATE) calibration system for the
Roche Single Strip System Glucose
Meter. Developed all system and component-level project
specifications. Developed templates, procedures and design documents
including Database Structure, Hardware and Software Requirements
Specifications, Mechanical and Electrical, and Unit and Integration
Tests, etc., to comply with 21 CFR Part 11 requirements, etc.
PROJECT
TITLE
TASK
Eli Lilly and Company (Pharmaceuticals), K103
Parenteral Manufacturing Facility Startup and Parenteral
Health and Safety Programs,Indianapolis ,
IN
(09/01 - 03/03) SENIOR TECHNICAL WRITER
Designed and developed operations and maintenance
procedure templates and procedures, such as; CIP, SIP, Data Historian,
Equipment Systems and Utilities Validation, Formulation, Filling, Freeze
Drying, Parts Washer, PUAF Unit and SCADA Operations etc., to support
the startup of the K103 Parenteral Manufacturing Facility and comply
with 21 CFR Part 11 and cGMP requirements. Designed and developed the
Parenteral Health and Safety Program Plan Template and Programs, such
as; Contractor Safety, Hazards Communication, Lockout Tagout and Lone
Operator, etc.
PROJECT
TITLE
TASK
Spartan Electronics, (Contract Electronics
Manufacturer (CEM)) Equipment and Facilities Operations Project,Brooksville ,
FL
(05/01 - 09/01) SENIOR TECHNICAL WRITER
Performed interviews and research, and
subsequently developed procedures to implement Just In Time (JIT),
Kanban and Lean Manufacturing practices. Met with and interviewed
management, engineering, operations and maintenance personnel.
Determined the appropriate basis standards and wrote and/or edited
standards and procedures to implement the program plan.
PROJECT
TITLE
TASK
Meister Electronics (CEM), Mass
Transit Systems Division, Bombardier, Hiawatha Project,Tampa ,
FL
(03/01 - 05/01) COMPLIANCE ENGINEER
Determined analyzed and ensured compliance of
components, equipment, materials and products with contract
requirements. Made Failure Modes and Effects Analysis (FMEA) and Mean
Time Between Failure (MTBF) calculations and provided documentation to
support compliance with contract requirements.
Met with Meister Electronics management and engineering personnel and
conferenced with Bombardier management and engineering personnel. Wrote
the Reliability Availability Maintainability and Safety (RAMS) Program
Plan and other supporting documents.
PROJECT
TITLE
TASK
Bayer Pharmaceuticals Plasma Fractionation
Products Facility, Facility Engineering Standards Policy and Program
Plan,Clayton ,
NC
(09/00 - 12/00) SENIOR TECHNICAL WRITING
CONSULTANT
Determined the requirements for, then designed,
tested and implemented, the Facility Engineering Standards Policy and
Program Plan. Determined the appropriate basis standards and wrote
and/or edited standards and procedures to implement the program plan.
Consulted with executive and senior management as needed to develop and
implement the program plan,
including the logistic and operational infrastructure.
PROJECT
TITLE
TASK
City, County and State Department of Public
Safety, Combined
EmergencyOperationsCenter ,
Austin ,
TX
(05/00 - 8/00) SYSTEMS INTEGRATION ENGINEER
Developed and
maintained the program level master plan and schedule. Developed and
implemented the program level document management plan, including the
support infrastructure. Developed and implemented the program level risk
management plan, including the support infrastructure. Assisted in the
development of the emergency operations center layout with city, county
and state management personnel and the architect. Advised client on
infrastructure design, network architecture and planning.
PROJECT
TITLE
TASK
Customer Service Website - United States
Automobile Association (USAA), (Insurance Company),
San Antonio ,
TX
(06/99 - 10/99) SENIOR TECHNICAL WRITERAND WEB DEVELOPER
Developed customer service internet website
e-commerce materials and templates.
Produced materials for software coding standards and wrote said
standards to meet the homogenized client, American National Standards
Institute (ANSI),
Institute of
Electrical
and Electronics Engineers (IEEE), International Standards Organization
(ISO) and Software Engineering Institute (SEI), Capability Maturity
Model (CMM), Level II software requirements. Developed customer service,
release two user guides, etc., for use by 40 infrastructure and software
developers and software test personnel on the website.
PROJECT
TITLE
TASK
Baxter Healthcare Renal Products (Medical
Devices), Division,
Meridian Project,
Largo
, FL (11/97 - 09/98) SENIOR ENGINEER AND TECHNICAL WRITER
Engineered the Research and Development (R&D),
department documentation system to support and minimize audit findings
in the Design History File (DHF), in preparation for the 510(k)
Submission to the Food and Drug Administration (FDA). Participated in
the R&D of medical devices from the perspective of FDA compliance
requirements. Advised client management on a daily basis. Developed
various systems and support documentation including the Project Plan
(PP), Product Launch Plan (PLP), Product Requirements Document (PRD) and
Software Requirements Specification (SRS), etc.
PROJECT
TITLE
TASK
Semitool Corporation (Semiconductor Production
Equipment), Corporate Maintenance and Training Program,
Kalispell ,
MT
(04/97 - 08/97) SENIOR TECHNICAL WRITER AND TRAINING MATERIALS DEVELOPER
Developed task and job skill requirements for the
installation, removal, repair, replacement and testing of components in
integrated circuit (IC), manufacturing equipment. Developed the methods
and procedures for the installation, removal, repair, replacement and
testing of components. Field-validated all instructions and procedures.
PROJECT
TITLE
TASK
Department of Energy (DOE), Fluor-Daniel
Corporation, Tank Farm Operations, Hanford Nuclear Energy Reservation,
Hanford, WA (11/96 - 02/97) SENIOR TECHNICAL WRITER
Reviewed Tank Farm operating procedures for
accuracy, usability and compliance with Basis for Interim Operation
(BIO), requirements and incorporated appropriate design, policy and
procedural changes, etc. Developed the procedures for the testing,
repair and replacement of components, loops and systems. Field validated
procedures.
PROJECT
TITLE
TASK
UnoVen Refinery, Babcock and Wilcox,
Lamont ,
IL
(09/96 - 11/96) TRAINING MATERIALS DEVELOPER
Researched task and job skill requirements for
unionized refinery workers. Developed lesson plans and various other
training materials for worker qualification. Developed and implemented
the use of Task Qualification Cards (TQCs). Wrote various TQCs.
PROJECT
TITLE
TASK
Entergy Integrated Solutions Inc.,
Memphis ,
TN
(01/96 - 07/96) BUSINESS CONSULTANT AND SENIOR TECHNICAL WRITER
Wrote business improvement process policies and
procedures. Produced management presentation materials for deregulated
business activities. Advised client on and initiated the ISO 9000
certification process and acquired appropriate software.
PROJECT
TITLE
TASK
DOE, Kaiser/Westinghouse,
Hanford Nuclear Reservation,
Hanford ,
WA
(03/94 - 05/95) SENIOR TECHNICAL WRITER
(Conduct of Operations (CONOPS), Consultant)
Wrote Annunciator Response, Emergency Operating,
Environmental Monitoring and Normal Operating Procedures (ARPs, EOPs,
EMPs and NOPs), for steam, water and wastewater plants per DOE Order
5480.19, "CONOPS Req’ts for DOE Facilities".
PROJECT
TITLE
TASK
Bussman ISO 9000 Certification Project,
Ballwin ,
MO
(10/93 - 12/93) ISO 9000 PROCEDURE WRITER
Reviewed ISO 9000 certification plans, policies
and procedures. Wrote instructions and procedures per ISO 9000
certification requirements for management, Quality Assurance (QA),
manufacturing, customer service, pick and pack, and shipping personnel.
PROJECT
TITLE
TASK
DOE, (MK-Ferguson), Weldon Spring EPA Superfund,
St. Charles ,
MO
(01/93 - 08/93) SENIOR TECHNICAL WRITER
Wrote plant procedures per DOE Order 5480.19, "CONOPS
Requirements for DOE Facilities", for the removal of wastes. Produced
lockout/tagout lesson plans and tests.
PROJECT
TITLE
TASK
DOE, Pinellas Plant (General
Electric/Martin-Marietta),
Largo
, FL (07/90 - 01/93) SENIOR TECHNICAL WRITER
(CONOPS Consultant)
Developed documentation templates. Wrote
operations and maintenance documents per DOE Order 5480.19, "CONOPS
Requirements for DOE Facilities". Received "DOE CONOPS Outstanding
National Achievement Award". Developed the Preventative Maintenance
Instructions (PMIs), per DOE Order 4330.4A, "Conduct of Maintenance".
PROJECT
TITLE
TASK
DOE, Westinghouse Savannah River Plant (SRP),
Aiken ,
SC
(03/90 - 07/90) SENIOR TECHNICAL WRITER
Wrote instrumentation and controls (I&C),
preventative maintenance (PM), calibration and functional testing
procedures for components, loops and systems to satisfy safety-related
program requirements. Produced various loop diagrams and drawings.
PROJECT
TITLE
TASK
ComanchePeak Nuclear Power Station,
Glenrose ,
TX
(10/89 - 12/89) INSTRUMENTATION AND CONTROLS SYSTEM ENGINEER
Performed I&C system scaling calculations
including, process variables, process control signals, instrument data,
head/tail corrections and error value methodologies, etc.
PROJECT
TITLE
TASK
TITLE
TASK
Nine Mile Point Nuclear Station,
Lycoming ,
NY
(03/89 - 10/89) BALANCE OF PLANT (BOP), I&C
COORDINATOR
Scheduled and tracked calibrations, etc. Calculated and assigned
setpoints, etc. IN-SERVICE INSPECTION (ISI),
ENGINEER (Document Review)
Reviewed ISI data for final acceptance and return-to-service. Validated
ISI results, etc.
PROJECT
TITLE
TASK
DOE, SRP, "K" Reactor Restart,
Aiken ,
SC
(11/88 - 12/88) RESTART ENGINEER
Wrote procedures to support DOE requirements for
the inception of a new position: Area Representative (AR). The AR had
overall responsibility for reactor area activities.
PROJECT
TITLE
TASK
DOE, E.I.
duPont, SRP,
Aiken ,
SC
(06/88 - 11/88) TECHNICAL WRITER
Wrote administrative, calibration and maintenance
procedures for Measurement and Test Equipment (M&TE) and process
instruments. Made walkdowns with procedures.
PROJECT
TITLE
TASK
Baxter Healthcare Products
(Pharmaceuticals),
Marion ,
NC
(02/88 - 05/88) TECHNICAL WRITER
Wrote sequence and theory of operation manuals for
various equipment and processes. Developed a Total Productive
Maintenance (TPM), program. Made presentations.
PROJECT
TITLE
TASK
RJR Mechanical Inc.,
Spartanburg ,
SC
(11/87 - 2/88) CONTROL SYSTEM ENGINEER
Specified, designed and started-up industrial
processes I&C systems. Specified, purchased and started-up CAD system.
Negotiated with clients and contractors.
PROJECT
TITLE
TASK
Strandberg Engineering Laboratories,
Taylors ,
SC
(8/87 - 11/87) FIELD SERVICE ENGINEER
Installed, calibrated and maintained textile
industry equipment, at all client facilities.
PROJECT
TITLE
TASK
Fluor-Daniel International,
Greenville ,
SC
(05/87 - 08/87) SENIOR TECHNICAL WRITER
Developed "Training The Instructor" materials.
Developed various system manuals.
PROJECT
TITLE
TASK
Mallinckrodt Diagnostics Division
(Pharmaceuticals),
Raleigh ,
NC
(01/87 - 04/87) TECHNOLOGIST
Developed Computerized Instrument Maintenance
System (CIMS), (FDA validation).
PROJECT
TITLE
TASK
Pigeon Point Refuse Derived Fuel Station,
New Castle ,
DE
(08/86 - 11/86) I&C STARTUP ENGINEER
Responsible for I&C systems startup including the
Distributive Control System (DCS).
PROJECT
TITLE
TASK
ComanchePeak Nuclear Power Station,
Glenrose ,
TX
(06/86 - 08/86) DESIGN VERIFICATION ENGINEER
Checked drawings against actual "As-Built"
configurations to verify design compliance.
PROJECT
TITLE
TASK
Instrument Society of
America (ISA),
TrainingCenter ,
Raleigh ,
NC
(03/86 - 04/86) LABORATORY ASSISTANT/INSTRUCTOR
Helped present "Process Instrumentation Theory,
Operation and Maintenance" course.
PROJECT
TITLE
TASK
United States Steel Corporation,
Gary ,
IN
(12/85 - 02/86) PROJECT ENGINEER
Implemented Computerized Instrument Maintenance
System (CIMS), processes.
PROJECT
TITLE
TASK
ArnoldAir Force Station, Missile & Rocket Test Facility,
Tullahoma ,
TN
(03/85 - 09/85) TECHNICAL WRITER/EDITOR
(PROCEDURE REVIEW)
Developed I&C procedures for the missile, rocket
and jet engine testing facilities.
PROJECT
TITLE
TASK
D.C.Cook Nuclear Power Station,
Bridgeman ,
MI
(12/84 - 02/85) LEAD I&C ENGINEER
Directed contractors. Performed a ten-year review
and update of I&C procedures.
PROJECT
TITLE
TASK
Shearon Harris Nuclear Power Station, New Hill, NC
(08/84 - 11/84) TECHNICAL WRITER
Wrote I&C procedures for Safety Related and other
systems in support of plant startup.
PROJECT
TITLE
TASK
Shearon Harris Nuclear Power Station, New Hill, NC
(08/84 - 11/84) TECHNICAL WRITER
Wrote I&C procedures for Safety Related and other
systems in support of plant startup.
PROJECT
TITLE
TASK
ClintonNuclear Power Station,
Clinton ,
IL
(06/84 - 08/84) ASSOCIATE I&C ENGINEER AND STARTUP TEST ENGINEER
Wrote I&C procedures for FSAR, Tech Spec and
Setpoint Document requirements.
PROJECT
TITLE
TASK
WaterfordIII Nuclear Power Station,
Taft ,
LA
(07/83 - 03/84) TECHNICAL WRITER
Wrote I&C procedures for components, loops and
systems. Performed walkdowns.
PROJECT
TITLE
TASK
Diablo Canyon Nuclear Station,
Avila Beach ,
CA
(03/83 - 05/83) TRAINING COORDINATOR
Implemented training of I&C technicians and
engineers. Assigned ANSI certifications.
PROJECT
TITLE
TASK
Palo Verde Nuclear Power Station,
Wintersburg ,
AZ
(04/82 - 03/83) TECHNICAL WRITER
Wrote I&C procedures for components, loops and
systems. Performed walkdowns.
PROJECT
TITLE
TASK
Allegheny Power Station,
Kittaning ,
PA
(07/81 - 11/81) QUALITY ASSURANCE SUPERVISOR
Ensured materials met design criteria. Signed
verifications. Trained some personnel.
PROJECT
TITLE
TASK
TITLE
TASK
San Onofre Nuclear Power Station,
San Onofre ,
CA
(08/80 - 04/81) TRAINING AND MAINTENANCE ENGINEER
Trained over 500 technicians in steam generator repairs. Directed
various repair efforts. TECHNICAL WRITER
Wrote procedures at the
WestinghouseNuclearServicesR&DCenter ,
Churchill ,
PA.
PROJECT
TITLE
TASK
Babcock and Wilcox,
Beaver Falls ,
PA
(05/74 - 08/80) VARIOUS
Various projects involving process controls and
precision measurement sciences.
SECURITY
Clearances Held:
Confidential, Secret, Top Secret and Cryptography
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