Project Manager Service

Frank A. Botelho

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

CARY, NC *****

919-***-**** CELL

EXPERIENCE SUMMARY

FRANK BOTELHO HAS OVER TWENTY YEARS OF EXPERIENCE IN THE BIOMEDICAL AND

PHARMACEUTICAL INDUSTRIES, HIS PROJECT MANAGEMENT EXPERIENCE INCLUDES

PROJECT PROPOSALS, PROJECT BUDGETS, VALIDATION, DOCUMENTATION, SUPERVISION

AND PERSONNEL TRAINING. FRANK IS CONSIDERED IN THE INDUSTRY AS THE SUBJECT

MATTER EXPERT (SME) IN THE AREA OF STEAM STERILIZATION AS IT APPLIES TO

AUTOCLAVE EQUIPMENT ENGINEERING AND DESIGN, CYCLE DEVELOPMENT, VALIDATION,

AND OPERATIONAL TRAINING.

Frank brings a broad range of experience, excellent organizational /

communication skills, excellent computer abilities (word processing,

spreadsheets, etc.) and a dedication to achieving project objectives to

every project he is involved with.

Major Responsibilities

. PROJECT MANAGEMENT

. Protocol / SOP development

. Protocol execution

. Equipment Optimization and Troubleshooting

. Data analysis and final report preparation

. Thermal Mapping

. Autoclave Cycle Development

. Cleaning Validation

. Solid Dosage Filling Line Validation

. Vaccine Filling Line Validation

. Client Training

. FAT / SAT participation

. Start-up of GMP facilities at various pharmaceutical and biotech

manufacturing and research facilities

. Coordination of the qualification effort with the construction management

personnel

ZB Validation Solutions LLC, Cary, NC

VICE PRESIDENT

BEN VENUE LABORATORIES, BEDFORD, OH

. ENGINEERING AND ASSESSMENT OF MECO PURE STEAM SYSTEM AND SEVERAL LARGE

ICOS AUTOCLAVES WHICH LED TO THE REDESIGNING AND RE-PIPING OF THE PURE

STEAM SUPPLY AND CONDENSATE AND PLANT STEAM AND CONDENSATE TO CORRECT WET

PACK AND STAINING ISSUES. PROGRAM CHANGES WERE MADE TO ENHANCE

STERILIZATION AND DRYING PERFORMANCE. REVISED THE PURE STEAM QUALITY

TESTING PROGRAM AND SOP AND TRAINED PERSONNEL ON PROPER TESTING

PROCEDURES. WROTE AND EXECUTED ENGINEERING STUDIES AND COMMISSIONING

PROTOCOLS. EVALUATED AND ADVISED ON THEIR ENTIRE STERILIZATION PROCESS

FROM WRAPPING AND PREPARATION, LOADING AND UNLOADING TECHNIQUES AND

EQUIPMENT TO CYCLE PARAMETERS, TESTING AND VALIDATION OF CYCLES AND

LOADS. ADVISED THE AUTOCLAVE VALIDATION TEAM ON INDUSTRY STANDARDS AND

REGULATIONS REGARDING CURRENT PRACTICES AND PROCEDURES TO FACILITATE

THEIR CONSENT DECREE MANDATE TO THE FDA WHICH WAS BEING MONITORED BY QXP.

GENZYME MANUFACTURING, ALLSTON LANDING FACILITY, ALLSTON, MA

. DEVELOPED, WROTE AND EXECUTED COMMISSIONING TEST PLANS (CTP), IQ AND OQ

PROTOCOLS, CYCLE DEVELOPMENT, PQ PROTOCOLS, FINAL REPORTS AND SOP'S TO EU

REGULATIONS AND REQUIREMENTS FOR THE FEDEGARI CGMP AUTOCLAVE FOR THE

GENZYME ALLSTON LANDING FACILITY TO FACILITATE THEIR CONSENT DECREE TO

THE FDA WHICH WAS BEING MONITORED BY QUANTIC. TRAINED PERSONNEL ON KAYE

TEMPERATURE DATA ACQUISITION SYSTEMS (VALIDATOR 2000) AND KAYE AND

PRESSURE SENSORS, AUTOCLAVE DESIGN & CONSTRUCTION, MECHANICAL, SERVICE,

OPERATION, TECHNIQUES, CYCLES & PHASES.

NOVOZYMES BIO-PHARMA INC., TIANJIN, CHINA

. DEVELOPED, WROTE AND EXECUTED IOQ PROTOCOLS, CYCLE DEVELOPMENT, PQ

PROTOCOLS, FINAL REPORTS AND SOP'S TO FDA GUIDELINES AND STANDARDS, AND

EU REGULATIONS AND REQUIREMENTS FOR THE SHINVA CGMP AUTOCLAVE FOR THE

NOVOZYMES API FACILITY. TRAINED PERSONNEL ON KAYE TEMPERATURE DATA

ACQUISITION SYSTEMS (VALIDATOR 2000) AND KAYE AND PRESSURE SENSORS,

AUTOCLAVE DESIGN & CONSTRUCTION, MECHANICAL, SERVICE, OPERATION,

TECHNIQUES, CYCLES & PHASES. ALSO TRAINED PERSONNEL ON CGMP

DOCUMENTATION PRACTICES AND PROPER VALIDATION PROCEDURES. PERFORMED

EQUIPMENT DESIGN CHANGES TO FACILITATE A MORE EFFICIENT OPERATION DURING

AN EIGHT (8) MONTH ASSIGNMENT IN TIANJIN, CHINA.

Eisai Inc., Research Triangle Park, North Carolina

. DEVELOPED, WROTE AND EXECUTED IOQ PROTOCOLS, CYCLE DEVELOPMENT, PQ

PROTOCOLS, FINAL REPORTS AND SOP'S TO FDA GUIDELINES AND STANDARDS FOR

FINN-AQUA AUTOCLAVES AND STERIS PARTS WASHERS FOR CLEANING VALIDATION FOR

THE PARENTERAL FACILITY OF EISAI INC. TRAINED PERSONNEL ON KAYE

TEMPERATURE DATA ACQUISITION SYSTEMS (VALIDATOR 2000) AND KAYE AND DATA

TRACE PRESSURE SENSORS.

. Developed, wrote and executed FAT / Commissioning Documents / IOQ

protocols to FDA guidelines and standards for a Vacuum Tray Dryer. Also

developed, wrote and executed IOQ protocols for the Process Air System

and HVAC Systems for the Encapsulation Room Project.

. Developed, wrote and executed IOQ protocols to FDA guidelines and

standards for numerous Controlled Temperature Units (CTU's) which

included Stability Chambers, Incubators, Isolators, Refrigerators, -20 C

& -80 C Freezers, Dry Heat Ovens, Depyrogenation Ovens, Warehouse and

Cold Rooms.

. Performed Cleaning Validation protocol final reviews, and performed

execution for Cleaning Validation of several Solid Dosage Filling Lines.

AMEC BioPharmaceuticals, Inc., Raleigh, NC

PROJECT MANAGER

MERCK, INC., DURHAM, NORTH CAROLINA

. CONDUCTED ENGINEERING STUDIES AND EQUIPMENT SHAKEDOWN, AS WELL AS

PERFORMING OQ ACTIVITIES FOR VACUUM FREEZER, SEVERAL LYOPHILIZERS AND

VACCINE FILLING LINE PROCESS.

Novo Nordisk, Clayton, North Carolina

. PROVIDED CGMP AUTOMATION DOCUMENTATION SUPPORT SERVICES FOR THE

DEVELOPMENT AND EDITING OF CRITICAL ITEMS LIST (CILS) AND CLASSIFICATION

OF REQUIREMENTS, DESIGN REVIEW AND TRACEABILITY MATRIX (COR'S) FOR

FORMULATION, MECHANICAL, STERILE STORAGE, FILLER SCADA, FILLER PLC,

WASHER-TUNNEL, AND PARTICLE MONITORING SYSTEMS.

Wyeth Vaccines, Pearl River, NY

. PROJECT MANAGER FOR CLEAN STEAM AND AUTOCLAVE SECTION OF A NEW LABORATORY

BUILDING. DUTIES INCLUDED VALIDATION OF MULTIPLE AUTOCLAVES AS WELL AS

THE COMPILATION OF ETOP'S AND EQUIPMENT DOCUMENTATION. OTHER DUTIES FOR

THE TEAM INVOLVED DEVELOPMENT AND EXECUTION OF VALIDATION FOR IQ'S, OQ'S

PQ'S, FINAL REPORTS AND SOP'S OF THE EQUIPMENT. AN ADDITIONAL PROJECT IN

A SEPARATE BUILDING ON SITE INVOLVED DEVELOPMENT AND EXECUTION OF SEVERAL

AUTOCLAVE ENGINEERING STUDIES, PQ'S AND FINAL REPORTS.

Wyeth Vaccines, Sanford, NC

. EXECUTED IQ'S FOR MULTIPLE AUTOCLAVES AND CIP SYSTEMS TO FDA, EU & MCA

GUIDELINES AND STANDARDS. TRAINED PERSONNEL ON KAYE TEMPERATURE DATA

ACQUISITION SYSTEMS (KL, 4S PLUS AND VALIDATOR 2000) AND VERITEQ WIRELESS

TEMPERATURE SENSORS.

Biolex, Pittsboro, NC

. PROJECT MANAGER FOR CLIENT'S 10,000 SQUARE FOOT EXPANSION PROJECT.

DUTIES INCLUDED ASSET INVENTORY MANAGEMENT AND TAGGING, AND PROJECT

BUDGETS. THE TEAM WORKED TOGETHER TO COMPILE ENHANCED TURNOVER PACKAGES

(ETOP'S), DEVELOPING, WRITING AND EXECUTION OF IQ'S AND OQ'S FOR VARIOUS

SYSTEMS AND INDIVIDUAL PIECES OF EQUIPMENT. THE SYSTEMS INCLUDED: HVAC,

RODI, COMPRESSED AIR, CONTAINMENT & BIO WASTE KILL, PLANT STEAM GENERATOR

AND THE EQUIPMENT INCLUDED AUTOCLAVE, GLASSWARE WASHER, FREEZERS,

REFRIGERATORS, MIXERS, TANKS, GROWTH ROOMS, ULTRA FILTRATION MODULES,

LAMINAR FLOW HOODS, BIO SAFETY CABINETS, FLOOR SCALES, BENCH SCALES AND

INCUBATORS.

Phoenix Imperative Inc., Raleigh, NC

VALIDATION PROJECT MANAGER

WYETH VACCINES, SANFORD, NC

. REVIEWED SITE ETOP'S AND FACTORY ACCEPTANCE TESTING (FAT) PACKAGES.

DEVELOPED AND WROTE IQ / OQ / PQ PROTOCOLS TO FDA, EU AND MCA GUIDELINES

AND STANDARDS FOR AUTOCLAVES AND OTHER VARIOUS PIECES OF EQUIPMENT.

Wyeth Vaccines, Pearl River, NY

. REVIEWED IQ / OQ / PQ PROTOCOLS TO MEET FDA GUIDELINES AND STANDARDS AND

REPORTED DEVIATIONS AND CORRECTIVE ACTIONS TO A FDA REPRESENTATIVE.

O'Neil Engineering Inc., Raleigh, NC

SENIOR VALIDATION SPECIALIST

. RESPONSIBILITIES INCLUDED BAYER CORPORATION, CLAYTON, NC AS CSCR

ADMINISTRATOR AND IQ / OQ / PQ PROTOCOL AND SOP DEVELOPMENT FOR

AUTOCLAVES AND PRESSURE CANS, GLAXO CORPORATION, RTP, NC FOR HVAC

COMMISSIONING, LEINER CORPORATION, FORT MILL, SC FOR IQ / OQ / PQ

DEVELOPMENT AND EXECUTION FOR SOLID DOSAGE TABLET LINES, COVANCE /

DIOSYNTH CORPORATION, RTD, NC EXECUTION OF IQ / OQ / PQ PROTOCOLS FOR

TRANSFER LINES, VALIDATION AND RE-QUALIFICATION OF THE FACILITY

AUTOCLAVES INCLUDING IQ / OQ / PQ / FINAL REPORTS, ADDENDUM'S, REVISIONS,

PROTOCOL DEVELOPMENT AND EXECUTIONS, DEVELOPMENT OF POWER POINT

PRESENTATIONS FOR AUTOCLAVE DESIGN, FUNCTION, OPERATION, DOCUMENTATION,

SAFETY, PACKAGING AND LOADING TECHNIQUES, PM'S CALIBRATIONS AND

VALIDATION ISSUES.

HAMO Sales and Service Corp., Miami, FL

NATIONAL SERVICE MANAGER / PROJECT MANAGER

. RESPONSIBLE FOR FIELD AND SENIOR FIELD SERVICE ENGINEERS, TECHNICAL

SUPPORT ENGINEERS, INSTALLATION TEAM TECHNICIANS AND CUSTOMER SERVICE

COORDINATOR. DUTIES INCLUDED MEETING MANPOWER REQUIREMENTS, TRAINING,

EQUIPMENT DESIGN MODIFICATION, DOCUMENTATION ISSUES FOR HOSPITAL,

LABORATORIES AND PHARMACEUTICAL VALIDATION PERSONNEL, SAFETY PROGRAMS,

PROCUREMENT OF SPECIALIZED TOOLS, OUTSOURCING OF PARTS AND CUSTOMER

PROBLEM SOLVING ISSUES.

. Promoted to Scientific Project Manager, responsible for customer

interface of product applications to include specific productivity and

utility analysis, post order submittal management and the orchestration

of delivery and installation of capital equipment. Tasks included

project proposals, project budget controls and the coordination for

assembly, installation and start-up of various sized washers between

union and no-union trades and HAMO Services Corporation. Assisted in

quote preparation of capital equipment and mediated between customer and

HAMO factory for customized accessories. Performed factory acceptance

testing (FAT) with customers, managed details and preparation of cleaning

validation documentation issues per FDA guidelines and represented HAMO

at national industrial and pharmaceutical trade shows.

Steris / AMSCO / Finn-Aqua Corporation, Erie, PA

SENIOR SERVICE TECHNICIAN / TRAINING INSTRUCTOR / SCIENTIFIC SERVICE

ENGINEER

. RESPONSIBLE FOR GENERATING A MINIMUM ANNUAL SALES / SERVICE OBJECTIVE OF

A LARGE GEOGRAPHIC TERRITORY. DUTIES INCLUDED THE SALES AND SERVICING OF

STERILIZERS, OPERATING ROOM LIGHTS AND TABLES. RESPONSIBILITIES INCLUDED

INSTRUCTION OF HOSPITAL PERSONNEL AND NEW SERVICE REPRESENTATIVE IN THE

PROPER USAGE OF THE AFOREMENTIONED EQUIPMENT AND FOR THE MARKETING OF ALL

COMPATIBLE PRODUCTS AND ACCESSORIES.

. Promoted to factory training instructor based in Erie, PA, responsible

for development and instructional delivery of technical training courses

in mechanics, plumbing, hydraulics, pneumatics, electrical, electronic

controls, validation and documentation issues, safety programs and

customer interaction skills for AMSCO service and sales technicians and

customers.

. Promoted to Scientific Service Engineer with efforts concentrated towards

the pharmaceutical market. Project Manager responsible for large cGMP

sterilizers, pure steam stills and pure steam generators manufactured by

Finn-Aqua. Duties included FAT, SAT, IQ, OQ assisting customers with PQ

development, equipment design changes, field service personnel and

customer technical calls, training and close working relationship with

engineering colleges in Finland.

Getinge / Castle / Sybron / MDT Corporation, Colorado Springs, CO

FIELD SERVICE REPRESENTATIVE / BRANCH SERVICE MANAGER / SENIOR TECHNICAL

SPECIALIST

. SERVICING HOSPITAL EQUIPMENT IN A TWO AND A HALF STATE AREA.

. Promoted in 1983 to Northwest Area Branch Service Manager. Additional

responsibilities included a six state sales and service area, managing

service technicians.

. Promoted to Senior Technical Specialist, which included consultations on

advanced equipment, seminar presentations and in-servicing of personnel.

Education

. NORTH CAROLINA STATE UNIVERSITY, RALEIGH, NORTH CAROLINA, COMPUTER

TRAINING UNIT (CTU), MICROSOFT PROJECT LEVEL I AND LEVEL II

. GE Kaye, Research Triangle Park, North Carolina, Thermal Validation

Seminar 3.0 Series

. 30 / 95 Credited hours towards Associated Degree, Applied Science, Saint

Regis College, Denver CO and Pikes Peak Community College, Colorado

Springs, CO

. Honorable Discharge, United States Army following 10 years of service

. Bio-Medical Equipment Repair Course, Fitzsimons Army Medical Center,

Denver, CO

. Castle Company Service Training School, Rochester, NY

. AMSCO Service Technician Training School, Erie, PA

. Erie County Technical Institute, Electrical Math Prep, Erie, PA

. Finn-Aqua Scientific Field Engineering Course, Finland

. HAMO Filed Engineering Course, Miami, FL

. GE Kaye Validator 2000 Seminar, Charleston, SC

. Barnett Seminar on Steam Sterilization, Washington, DC

Memberships

. INTERNATIONAL SOCIETY OF PHARMACEUTICAL ENGINEERS (ISPE), VENDOR

COMMITTEE MEMBER (CASA)

. Boy Scouts of America (BSA), Assistant Scoutmaster Troop 204, Cary, NC

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