GERARDO TORRES

Urb. San Agustn Calle San Alfonso #23

Vega Baja, Puerto Rico 00693
(787)232-6809 (787)310-6766
e-mail: ptgsa23@yahoo.com

PROFILE:
Engineering Technician and Maintenance Specialist with a successful career record within the Service, Building
Projects, Electro-mechanical, Chemical, Pharmaceutical, Biotechnology, Solid Dosage, Medical Devices industries,
Maintenance and R&D Projects field assuring the continuous quality, performance, improvement, maintenance program
and compliance requirements related to process, manufacturing, production and engineering departments by means of
strong team work culture and solving problem techniques. Excellence professional assess skills for engineering,
production, manufacturing and maintenance projects. Technical reports development and Team facilitator experiences.
Proven metrology expertise and experienced. Extensive trained and experience on GMP, ISO, OSHA, World Class and
LEAN culture, FDA validations, calibration and maintenance programs, quality audits and team work. Lead project
objectives and schedules. Strong knowledge on engineering drawings; P&ID, As Build, BOM, Design & product specs.
Experience inspecting equipment and instrumentation installation according to P&ID prints, ISA standards and instrument
specifications. Skills for develop an engineering document system. Competitive knowledge and experience to performing
assessment for calibration and maintenance projects. Self oriented and trained on maintenance, calibration and quality
standards (SAE, NCSL, ISO, NIST, GLP, USP, MIL STD, ASTM and ANSI). Experience using statistic quality tools for
engineering evaluation and G R&R. Trained in CAPA procedures and system flow. PC literacy; Microsoft Windows, Word,
Excel, Word Perfect, Power Point, Web Sites & Internet.

Management exposure to Engineering Projects at Medical Devices, Biotechnology, Pharmaceutical and Water
industry.
Focused on customer satisfaction with high level of culture service and professional ethics.
Strongly oriented to compliance and quality culture.
Accountability on quality system documentation, training program compliance, validations procedures, process
manufacturing requirements, equipment operations and maintenance system.
Development IQ/OQ/PQ protocols and execution for engineering, production, manufacturing, facilities, utilities, Q.C.
laboratories and much others.
Conduct quality audits for departments of engineering, Q.C. labs, manufacturing, production operations, warehouse,
technical services and quality and related documentation.
Perform engineering evaluation for product testing and quality issues.
Development testing procedures for production materials, components and products.
Development production certifications and examine operators qualifications.
Development of standard operating procedures and engineering documentation system for calibration, maintenance,
manufacturing and production operations and machinery.
Development engineering system documentation for maintenance program of industrial equipment.
Strong knowledge commissioning instrumentation systems.
Trainer for calibration practices, manufacturing equipment operation, validation and manufacturing instructions and
SOP procedures.
Development and analyze specifications for instruments, instrumentation systems, calibration methods, equipments,
test equipments, operations, manufacturing and validation.
Submission to regulatory affair for approval on changes in equipment, specifications, process and documents.
Direct participation on assessment, purchasing, installation, qualification, validation and servicing equipments,
machines, instrumentation and computerized systems such as: Manufacturing and Production Lines, Vial Fillers,
Packaging lines, Vials and Stopper Washer, Glass Washer, Bioreactors, CIP units, Chromatography columns, Dryers
Units, Sterilizers, Bach Tanks, PLC, High Purity Steam/Water Generator, WFI Columns, Temperature and Humidity
Controls, Particles Counters, Control Panels, Soft and DI/ROW Waters units, HVAC, Clean Rooms, Lab Centrifuges,
Scales and Balances, Ovens and Incubators, Vision systems, Microscopes, Pull Testers, Staking units, Sealer
machines, Printers and bar codes and much others.
Good skills handling PM computerized programs and their utilities and documentation systems (CalPro, CalMan,
MP2, Windchill, DAS, CATSWEB, DOCS, View Point, GTMS) and electronic multitask copiers (scanner, fax, files).
Experience on validation test equipments (Kaye Validator system and oldest Digistrip machines).
Metrology leadership for the pharmaceutical, biotechnology and medical devices industries and calibration vendors.
Consultant and supervisory experience on maintenance and calibration project for the Water industry.

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GERARDO TORRES
Urb. San Agustn Calle San Alfonso #23
Vega Baja, Puerto Rico 00693
(787)232-6809 (787)310-6766
e-mail: ptgsa23@yahoo.com

PROFESSIONAL EXPERIENCE

PDMTECH, INC.
Maintenance & Reliability Engineering Specialist, Vega Baja, P.R.
Feb 2012- Present Date
RCM Oprimization projects for the Water and Pharmaceutical industry
o Optimization Techniques: RCM, FMECA, TPM, RCT
o Completed projects ; Water Filtration & Treatment plants, Lyophilizers, CIP/SIP Unit, Diafiltration Skid and
Packaging line
FMEA
o Team meetings to develop failure mode effect analysis and FMCA templates.
RCA
o Reliability critical analysis for driven assets management decisions.
o Maintenance strategies assignment on critical assets (TB/CB/FF/OM/DO)
Job Plans Redesign
o Maintenance task consolidation on current Job Plans
o Develop new maintenance Job Plans and task
Project reports
o Presenting to client RCM data, results and conclusions
o Report to client proposed design out and others recommendations
Other Project completion
o Assessment on Calibration Confidence for CAPA completion
MAQUET
R&D Project Technician IV
Dorado, P.R.
August - December 2009
MAQUET Transfer project: Support for CS Division and R&D Project and Transfer Team
Components Testing for Rebranding Project
Direct participation in the Decommissioning P.R. Project Team:
o Assurance on instrument, equipment and tooling inventory
o Feature list for tracking inventory and status report
o Comply with procedures for equipment decommissioning
o Support LENs process and close the loop
o Comply with quality documentation
o Comply with equipment transfer to Wayne, N.J.
o Provide quality storage for decommissioned inventory
o Task force for equipment and layout removal, retiring and safe scrap and discard
DAY & ZIMMERMANN : VALIDATION SPECIALIST I
Professional Services
MAQUET, Dorado, P.R.
August, 2008 July, 2009
MAQUET Transfer project: Support for CS Division and R&D Project and Transfer Team
Develop IQ/OQ validation protocols and reports for testing and production equipments and material components
Peer review meeting for validation plans, process and approvals.
Develop and review news and current Standard Test Method (STM) and Manufacturing Process Instructions (MPI)
Electronic Change submission for Quality approval and Regulatory Affairs.
Training technical group and equipment users.
Technical support on equipment or operational failures
Assessment on Component Qualification Plan, Validation and Data Analysis process (QST)
Engineering evaluation to solve product testing issues (failure analysis, corrective action and tracking system)
Assessment on LHR documents MPI traceability
Documentation process: quality system documentation for testing, data analysis, validations, calibration, maintenance
Direct participation in Validations, Qualification and Engineering projects: Pull Testers, Molds, Failures Lots, Supplier
materials, Company Rebranding, Printers & Scanning.

Support to close quality issues thru CAPA system.

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GERARDO TORRES
Urb. San Agustn Calle San Alfonso #23
Vega Baja, Puerto Rico 00693
(787)232-6809 (787)310-6766
e-mail: ptgsa23@yahoo.com

VALIDATION & INTEGRATION GROUP: CALIBRATION & MEASUREMENT CONSULTANT

Professional Services
Wyeth Guayama/Carolina, P.R.
Sept. 2007- May 2008
Support on data migration from CalPro to CalMan Calibration Program
Calibration data cleaning on Master Data Trammital
Verification and updates instrument and calibration specifications
Collect Calibration Program Master document
Verification and evaluation of Calibration Program Master document
Corrections of calibration specifications into Calibration Data Templates (CalMan)
Data entries in CalMan Program.
Solve gap issues for instruments in Schedule Master List
Assessment to client to solve specification issues in calibration
Assessment to client for calibration specification foundation
Assessment to client to improve calibration methodologies.
General support for Project Team.
PCG CORPORATION: CALIBRATION SUPERVISOR FOR THE MAINTENANCE PROJECT
Professional Services: Triple AAA of P.R.
Manat / San Juan, P.R.
May 2007- October 2007
Supervise new project of calibration and maintenance for instrumentation.
Team work: meetings, feedback, up-dates, communications, weekly reports
Supervise teams visiting client facilities.
Supervise data of instrumentation inventory.
Support to consultant team and engineering department of client.
Assessment to assure quality data on instrumentation information, data and manuals.
Lead collection of technical information, manuals and maintenance data.
Develop calibration and maintenance plans and procedures.
Assessment and development of instrument and process specifications.
Assessment to list and recommend test equipment and precision tools for maintenance and. calibration.
Assessment to list and recommend spare parts for preventive and corrective maintenances.
Assessment to develop the calibration compliance process for outsourcing.
Assessment on calibration cost from client comparing to out-sourcing.
CADILLAC UNIFORM : MAINTENANCE CONSULTANT
Professional Services: Cadillac Uniform
Bayamn, P.R.
Assessment on quality goal for a maintenance program of clean room area.
Assessment on maintenance documentation system for production equipment.
Evaluation on actual PM program to develop reliable procedures.
Evaluate PM tasks programmed in MP2
Collect equipment manuals and current PM tasks for PM revision.
Interview to equipment owners and users for technology recognition
Develop maintenance procedure program and PM system procedure.
Develop plans and PM procedures.
Recommendations to ensure an effective implementation of PM program.

April 2006 July 2006

Page 4

GERARDO TORRES
Urb. San Agustn Calle San Alfonso #23
Vega Baja, Puerto Rico 00693
(787)232-6809 (787)310-6766
e-mail: ptgsa23@yahoo.com

SENIOR R&D PROJECT TECHNICIAN (PROCESS QUALITY)

Guidant P.R.
Dorado, P.R.
February, 2001- March, 2006
Direct participation in Project Management as member of R&D Engineering and Manufacturing Project Teams.
Direct participation in product builds for operation and process assessment.
Acting as engineering lead project: readiness meetings, schedule milestones, coordination, team resources.
Development and execution of written reports for equipment and process Validations (IQ/OQ/PQ).
Lead process review validation meetings: validation development, test results, specifications, protocol approval.
Provides technical services to processes and production /pilot lines.
Solve compliance issues; root causes analysis, G R&R, process impact (Inspections, MRB and CAN).
Responsible to comply with remedial action notice process for calibration and equipment out of specifications.
Certifications development for process and equipment operations and operator certifications.
Responsible for the maintenance in schedule of production equipments and close documentation in MP2 program
Development and revisions for procedures of equipment operation, operations, maintenance, calibration, product testing.
Capital assessment, request and management for purchasing equipment, tool, tooling and support.
Assessment to determine equipment, process and manufacturing specifications.
Evaluates, recommend, order, installs and train for new tools, fixtures, equipments, machines and software.
Performs and document equipment setup and corrective, preventive and calibration maintenance (MP2 Program)
Evaluation and assessment on automation projects implemented in production operations: report deficiencies, quality
issues, recommend corrections and implement new changes.

ADDITIONAL EXPERIENCE
RLN Properties- Up John Pharmaceuticals, Arecibo, P.R.
FJR Properties- Schering Plough, Manat, P.R.
Senior Instrumentation Technician- Ortho-McNeil Pharmaceutical, Dorado, PR
Instrumentation & Metrology Group Leader- Ortho-Biologics, Manat, PR
Instrument Technician & Validations- Sterling Pharmaceuticals, Barceloneta, PR

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GERARDO TORRES
Urb. San Agustn Calle San Alfonso #23
Vega Baja, Puerto Rico 00693
(787)232-6809 (787)310-6766
e-mail: ptgsa23@yahoo.com

EDUCATION, COURSES AND TRAININGS

Technological Institute of Puerto Rico

Manat Campus, P.R.

ASSOCIATE DEGREE IN ENGINEERING OF INSTRUMENTATION TECHNOLOGY

JOHNSON & JOHNSON SHARED SERVICES
Analytical Troubleshooting

QUALITY IMPROVEMENT TRAINERS, INC

Academy of Advanced Audit Skills
GMP & ISO 9000 Approach to:
Measurement & Calibration Systems

DPTO. INGENIERIA INDUSTRIAL UPR

Curso de Estadsticas Industriales

FLUKE GROUP
Principles of Metrology

BLUE MOUNTAIN QUALITY RESOURCES

Regulatory Aspects of the Calibration Program

RITUORT & ASSOCIATES

Audits in FDA and Regulated environment
The New Role of the Quality Inspector
GMP Practices

QUALITY FOR BUSINESS SUCCESS

Quality Standards ISO 9000

CONDITION MONITORING INSTITUTE

EQUIPMENT ALIGNING & BALANCING
Vibraciones Nivel I

KAYE INSTRUMENTS
Validations Seminars
Instrumentation Services

PRODUCTIVITY POINT
Computer literacy in Microsoft Windows

ROCKWELL AUTOMATION
Allen Bradley
Maintenance & Troubleshooting - SLC 500 Family
Programmable Logic Controllers

JR ELECTRONICS
Programmable Logic Controllers
Pneumatic Technology

CONFIDENCE IN SOFTWARE
Validation of Programmable Logistic Controllers

D&Z TRAINING PROGRAM

GMP Documentation Compliance
E-Compliance Course

CONDITION MONITORING & MAINTENANCE INSTITUTE

RCM- Reliability Centered Maintenance Certification

COLEGIO DE INGENIEROS
Inspecciones Proyectos Elctricos

Extensive trainings in RCM, FMEA, RCA, TPM, QSR, GMPs, SOPs, Engineering system procedures, Quality
Document Systems, OSHA regulations and Environmental.

REFERENCES
Available upon request