Phone 787-***-****

787-***-****

P.O. Box ***4

Arecibo, PR 00613-8094

e-mail: acaklj@r.postjobfree.com

Guillermo Cancel Lugo PE 11258

Curriculum Vitae

Work

Experience 2005 (April) to Current Bristol-Myers

Squibb Manati, PR

Senior IM CSV Specialist

Actually assigned to provide IM leadership on computer validation

for Serialization with Barcode

Labeling for secondary packaging lines. Support to Automatic

Inspection Project for syringes / vials

for Orencia IV and Orencia SC, Automatic Assembly Project for

Safety Syringe / Auto Injector with

secondary packaging line for Orencia SC. In charge of maintenance

of CSV Master Plan and CSV

Periodic Review Plan for the site. Also provides CSV support to MES

implementation using Syncade

Application with Delta V interface for eBR. Execution of FAT in

Japan for Kyoto Tray Loader Machine for

for vials Automatic Inspection Project. Align CSV program to

support regulatory agencies inspections.

On previous years provide IM/CSV leadership to Orencia SC Launch

Process Alignment Team and

Bio-Packaging Process Alignment Team. Include responsibility for

CSV documentation life cycle of the Erbitux and Orencia SC

Inspection and Packaging new lines. Execution of FAT's for Weiler

Labeler and Erbitux Packaging Line Control, components of the new

line. Performed addendum to add Manufacturing Date to packaging

components of the Orencia Secondary Packaging Line. Execution of

CSV life cycle for Lighthouse Vista /P In-Line Vacuum system

including FAT. Assigned to provide CSV leadership to the Manati

Sterile Expansion (MSE) project. Responsible to assure compliance

with CSV policies & procedures, including the coordination for the

issuance of CSV life cycle applicable deliverables for SKAN

Isolator and Bosch Filler Line validation. Execution of FAT's for

SKAN Isolator, BOC Edwards Lyophilizers and Sani Matic CIP/SIP.

Execution of CSV life cycle for a Bosch Isolator as part of the

Manati Syringe Renovation (MSR) project. Additionally provide

support in the site, for the revision and approval of CSV life

cycle documentation and Systems Administration duties.

2004 (January) to 2005 (April) Bristol-Myers

Squibb Manati, PR

Senior IM Quality Systems Specialist

Project Leader for the Non-Chromatography ERS remediation project.

This responsibility

includes, project management, validation support, vendor

interaction, procurement, capital

expenditure request, quality compliance and systems administration.

Act as backup support

for LIMS and Data Acquisition applications.

2003 (March) to 2004 (January) Schering-Plough

Manati, PR

Manager Quality Computer Systems

In charge of provide support to all Quality Operations computer

applications. Act also as Site

Quality Coordinator for Worldwide Quality IS. Liaison to IT and

Computer Validation areas

for Quality Computerized Systems. Quality Operations main contact

for re-validation of LIMS,

Millenium and Stand-Alone Systems.

2002 (April) to 2003 (February) Schering-Plough

Manati, PR

LIMS Manager

In charge of LIMS application support to Quality Operations area.

Liaison to Information

Technology and Computer Validation on Laboratory Computerized

Systems. Responsible for

Remediative Actions for Consent Decree on Laboratory Computerized

Systems. Provide to

Q.C. Laboratory, support on Millenium, Computer Stand-Alone and

Spreadsheets systems.

2001- 2002 Pfizer

Vega Baja, PR

Senior IS Technical Support

Provide support to IS systems under Technical Operations. These

activities consists of Servers

Administration (HP9000), Oracle Database Administration, Liaison to

Laboratory operations,

Data Center Management and Validation resource for the area. Act as

backup to IS Technical

Manager.

1996-2001 Warner-Lambert, Inc.

(Pfizer) Fajardo, PR

Senior Quality Systems Support

Provide support to IS systems under Quality Operations. These

activities consists of Servers

Administration (HP9000), Computer Stand-Alone Systems Security, Lab

Manager/PeakPro

System Manager and System Validations. Standard Operating

Procedures development as

required for applications management. Provide support to IS site

operational areas. Act as

IS site backup to Department Manager.

1994-1996 Warner-Lambert, Inc. Fajardo, PR

LIMS Administrator

In charge of LIMS system Implementation. This includes

Installation, Validation, Release,

Administration and Change Control. Provide support to all

laboratory computer systems. As

part of the validation efforts for the LIMS system implementation

the following validation

deliverables were developed or reviewed; Validation Plan,

Validation Protocol, System

Requirements and Specifications. Provide guidance to Quality

Operations on Computer

Validation discipline.

1992-1994 Warner-Lambert, Inc. Fajardo, PR

Automation Instrumentation Supervisor

In charge of computer automation on the Q.C. Laboratory.

Supervision of Laboratory

Instrumentalist. Beginning phase of LIMS system Implementation.

Validation support to

Laboratory operations. Member of Corporate Computer Validation

Steering Committee

in charge of Computer Validation Policy development and

implementation.

1991-1992 BBDO Advertising Agency San Juan, PR

EDP Manager

In charge of all data and voice infrastructure on the site. Network

installation, computer

trouble-shooting and vendor's support contracts. Provide support to

Accounting and Payroll

Operations.

1989-1991 LIH Advertising Agency San Juan, PR

Programmer

In charge of computer programs development, troubleshooting and

implementation. Hardware

and Software installation. Customer support to all site

computerized operations. Act as

backup to EDP Manager.

Education 1989 University of Puerto Rico Mayag ez A & M Campus

B.S. Computer Engineering

Courses

TrakSYS Basic Training Course - Parsec

Interacting Skills for Success / Influencing Others - Development

Dimensions International

Custom Compliance Suite - Emerson Process Management

BMS Process Automation System - Rockwell Automation/PR

PI Process Book and PI Data Link - OSIsoft, Inc.

ControlLogix Maintenance & Troubleshooting - Warren del Caribe

(Rockwell Automation)

Computer Products Supplier Auditing Process Model: Auditor Training

PDA TR-32

ControlLogix Fundamentals- Warren del Caribe (Rockwell Automation)

Enterprise/ Control System Integration Using ISA-95.00.01-2000 -

ISA Training Institute

Batch Control Using the ANSI/ISA-88 Standards - ISA Training

Institute

Certified Computer System Validation Professional - Stelex

University

Risk Assessment Workshop - Stelex University

Kepner Tregoe Refreshment Training

System Administration for SUN Solaris 8

Enterprise DBA Part 1B: Back-up and Recovery (Oracle)

Labor Law Seminar (Pfizer Global Manufacturing Vega Baja)

HP-UX System & Network Administration for Experienced UNIX System

Administrators

Introduction to ORACLE SQL & PL/SQL

ORACLE 8: Database Administrator

Train the Trainers Workshop in Warner-Lambert, Inc.

UNIX System Basics

HP-UX System Administration Basics

PeakPro System Administrator

LabManager System Administrator

Knowledge

FDA and cGMP regulations

21 CFR Part 11

Computer Validation and System Development Life Cycle Methodology

Project Management

Risk Assessment

System Impact Assessment & Component Critically Assessment

TR-32 Audit of Suppliers of Computer Products

Serialization

Membership College of Engineers and Land Surveyors of P.R. PE 11258

s Parenteral Drug Association Certificate of Accomplishment No. 1241,

Auditor of Suppliers of

Computer Products and Services; Audit Process

Reference Available Upon Request

Contact this candidate