1. RESUME
JULIO A COLON MALDONADO
Laurel BB7, Quintas de Dorado, Dorado PR 00646
Telefono:787-454-2415
E-mail;juliocolon62@yahoo.com
OBJECTIVE
To use my technical process and investigation experience to contribute to the industryin the
manufacturing,qualitycompliance and maintenance industryareas.I also wantto be a useful resource
to the much needed results-oriented workforce.
PROFESSIONAL EXPERIENCE
Sr. Consultant/Validation Specialistuntil October 2008
Validation & Engineering Group,San Juan PR
Provided services as an independentcontractor to the St Jude Medical facility in Arecibo PR supporting
the validation protocol execution for manufacturing clean room qualification (non-viable particle counts)
and utilities such as high purity gases/gas mixtures and potable (drinking) water system. Other duties
included problem-solving efforts in supportofthe gas:distribution system qualification.*
Sr. Consultant/Investigator 2007-2008
Validation & Engineering Group,San Juan PR
Provided services as an independentcontractor to the Procter & Gamble Pharmaceuticals facilityin
Manati PR. Duties included preparation ofinvestigation reports for quality variances and incidents in
tablet manufacturing,chemical process and equipmentcleaning validation (CIP).Other duties included
preparation ofvalidation supporting documents and evaluation ofcleaning validation procedures.
Sr. Consultant/Validation Auditor 2006-2007
Validation & Engineering Group,San Juan PR
Provided services as an independentcontractor to the Amgen Manufacturing Limited facility in Juncos
PR for the biotechnologyprocess and cleaning validation.Specific duties included validation reports
auditing,monitoring and identification ofprocess trends,status and progress charts/reports and
submission ofrecommendations ofrelated preventive actions tools.Other duties included preparation of
validation supporting documents as needed.
Sr. API Technical Specialist 2000-2005
Pfizer Pharmaceuticals LLC Chemical Operations,Barceloneta Puerto Rico
Coordinated the Cleaning Validation Program and functioned as member of the Site Validation
Committee.Duties included preparation,revision,evaluation and execution of process and cleaning
validation protocols and execution of QA and Compliance projects.Supported the implementation of the
Incidents and Deviations Handling Program as a trainer/facilitator.Identified process trends for process
control through scheduled internal audits. Provided directsupportto process problem solving,
investigation reports and supportto the change control program.
EDUCATION
Bachelor Degree in Chemical Sciences (1976):Universityof PR at Rio Piedras,PR.
Master in Chemical (Physical) Sciences (1980);Universityof PR at Rio Piedras,PR
REFERENCES
Available upon request.