Manager Project
Resume:
Phone 787-***-****
P.O. Box ***4
Arecibo, PR 00613-8094
e-mail: *******@*********.***
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
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