1. EFRAÍN RODRÍGUEZ MARRERO
CHEMICAL ENGINEER
EFRAIN RODRIGUEZ MARRERO 1
SUMMARY OF QUALIFICATIONS
Chemical Engineer with experience in several
engineering aspects including: State and
Federal Regulations, Validations, Permits, and
Environmental. Manufacturing experience
includes IQ, OQ, and PQ validation of industrial
equipment and also EHS engineering.
Experience with URS (User Requirements
Specifications) and RBP (Risk Based Project
Plan). In addition, exposure to ISO standards,
GDP, cGMP Final Rule, Quality System
Requirements(QSR),SafetyTrainings,and others.
PROFESSIONAL EXPERIENCE
Pfizer Consumer, Guayama, P.R. (Nov–Dec 2015)
Senior Validation Consultant
Professional Services as Senior Validation Consultant for Gemco Blender “A”
improvements made during the shutdown.
IOQ documentation support for Centrum Optimization Weight & Dispense automated
manufacturing system at AZO Room 266.
Trained and Certified in Pfizer Standards and over ninety (90) others aspects provided
by LRN Legal Compliance and Ethics Center.
McNeil LLC, Las Piedras, P.R. (Feb–Apr 2015)
Validation Engineer
Professional Services as Validation Engineer for QC Analytical Laboratory.
IOQ and PQ documentation relatedto LANCER 1600 UP Laboratory Glassware
Washer/Dryer.
Trained and Certified in cGMP and over forty (40) others aspects provided by UL
EduNeering.
Zimmer, Ponce, P.R. (July–Oct 2014)
Senior Validation Specialist
Professional Services as Senior Validation Specialist for Project Trident.
Revision of OCP, ZWI and several documents related to MIELE Washer/Dryer at Cells 203
and 233.
Cell. Phone: (787) 457-8641
Home Phone: (787) 714-0459
Urb. Treasure Valley
México Street B-11
Cidra, P.R. 00739
E-mail: efrainrodri@gmail.com
For more INFO. Please visit:
www.efrainrodriguezmarrero.tk
Areasof Expertise:
Validations, Medical Device,
Pharmaceuticals, Manufacturing,
Environmental and State / Federal
Regulations
2. EFRAÍN RODRÍGUEZ MARRERO
CHEMICAL ENGINEER
EFRAIN RODRIGUEZ MARRERO 2
Trained in use of Kaye Validator and all SOP’s and documentation related to Warsaw
and Ponce, Zimmer Operations.
Merck, Las Piedras, P.R. (Nov–Dec 2013)
Validation Specialist
Qualification support for Tablet Press and revision of CCR’s (Construction Completion
Reports). All related to the IQ (Installation Qualification).
Advanced Project Group, Canóvanas, P.R (2005 – 2007)
Validation Specialist
Pall Life Science, Fajardo, P.R., (Jan.–Apr. 2007)
OQ/PQ for the Criterion SPC Vantage software for manufacturing operation.
Operational and PerformanceQualification (OPQ) for the CriterionTM
SPC Vantage software
to manufacturing activities in departments 10, 11 and 19. This software is a collection of
integrated Windows applications which enable Pall LifeScience to collect, store, organize and
analyze quantitative (variable) and qualitative (attribute) production data. Criterion™ SPC
Vantage software help to reducewasteand raisethe quality of their products. Also, works toward
automatingthe utilization of SPC techniques, and can be usedin largeor small manufacturing
environments.This softwareis an “off-the-shelve” softwaredeveloped by Siemens Measurement
Systems Business designedfor use on a network, andallows workstations to sharerelevant
configuration and production data as soon as itis available.
IQ/OQ for REVCO Laboratory Refrigerator/Freezer.
Installation and Operational Qualification (IOQ) was performed for the REVCO Laboratory
Refrigerator / Freezer in Pall (PPR). The Refrigerator / Freezer will be used to storage solutions
in accordance with the manufacturer’s recommendations.
Environmental Health and Safety
& Validation Engineer
BD Caribe Ltd., Las Piedras, P.R., (July 2005–Oct. 2006)
Temporary EHS (Environmental Health and Safety) engineer.
The main responsibilities were write and evaluate several monthly reports including
PRASA according with the permit approved, SWDA new recycling program required by
law and DNER monthly well report. Related with OSHA, over two hundred (200)
employees were supervised directly covering all departments. Coordinatedand played
3. EFRAÍN RODRÍGUEZ MARRERO
CHEMICAL ENGINEER
EFRAIN RODRIGUEZ MARRERO 3
integral part in achieving a 3-year contract between BD Caribe Ltd. Las Piedras and
Multi-Recycling Systems Inc., resulting in over $20k annual cost reductions.
Equipment validation (IQ, OQ, PQ) for CoilMate/Dickerman Servo Feeder installed to
improve the operation of Minster #2 punch press machine.
Revision of SOP’s, PM, Utilities, and Safety.
Engineering studies and solutions to meet FDA, CFR’s, and ISO requirements.
Trained in use of QDMS 3.0 (Quality Documentation Management System).
Environmental Engineering Study to document improvements made to
Assembly/Packaging and Sorting/Inspection Cleanrooms in accordance with ISO 14644-1.
Engineering Consultant, Cidra, P.R. (2002 – 2005)
Quality Control Inspector (Temporary): Millipore, Cidra P.R.
Process Control (Temporary): BD CaribeLtd., Cayey, P.R.
Q/A Engineer (Temporary): Tech CBI Group, Cidra, P.R.
Environmental Quality Board (EQB), San Juan, P.R.
Caribbean Refrescos (Coca-Cola), Cidra, P.R.
Ray Architects & Engineers, San Juan, P.R.
EDUCATION
B.S. Chemical Engineering
University of Puerto Rico, Mayagüez
Professional Societies/Affiliates
College of Engineers and Land Surveyors of Puerto Rico (CIAPR), EIT
Institute of Chemical Engineers (IIQ).
Specialized Training
2015/ Expose to URS (User Requirements Specifications) and RBP’s
2015/ Trained and Certified in cGMP and others
2014/ KAYE Validator knowledge
2014/ Gage R&R (MiniTab) knowledge
2001/ HAZMAT (40-hours) – OSHA
1995/ Hazardous Material Transportation – DOT