Engineer Quality Assurance
Resume:
OBJECTIVE
Seeking a position in the areas of validation, process engineering,
technical support or quality assurance. However, other areas will be
considered.
EDUCATION
May 2001-University of Puerto Rico, Mayag ez Campus
> Bachelor Degree in Chemical Engineering
> Manufacturing Engineering Certificate
WORK EXPERIENCE
December, 2008 to Present
Eli Lilly - Guayama, PR
Validation Engineer - ECS contractor
> Developed VPL, URS, TPL, SOV, SCS, IQ, MDL and TMX documents for a
computer control system. Updated DS, SEC, BCP, DRP documents. Currently
executing the IQ for this control system which includes a PLC with
SCADA and is intended for an API micronization. The mechanical system
includes a jet mill, glove boxes, screw feeder, rotary valves, drum
weight stations, temperature and oxygen transmitters among others.
Also, a Validation Report was generated for a new nitrogen generation
system.
October, 2007 to November 2008
Wyeth Pharm - Carolina, PR
Validation Engineer - ECS contractor
> Developed and executed Commissionings for the Engineering Department,
which included HVAC projects, Utilities Control Room expansion and
Compressed Air Dryers. Executed CSV tests for the Foxboro and Honeywell
Building Management Systems.
June, 2007 to October, 2007
Eli Lilly - Guayama, PR
Validation Engineer - ECS contractor
> Executed Commissionings, Installation and Operational Qualifications
for a new chemical plant facilities expansion (API). This project
includes the validation of chemical reactors and all their related
equipment (piping, valves, steam traps, filters, indicators,
transmitters, pumps, glove box, blower, etc).
April, 2005 to June, 2007
Wyeth Pharm - Carolina, PR
Validation Engineer - PVSR contractor
> Performed cleaning, facilities and equipment validation
(Commissionings, IOQ and PQ). These projects include the validation of
equipment for a new drug manufacturing process (piping, valves, steam
traps, filters, indicators, transmitters, pumps, formulation tanks,
glove box (isolator), etc). Cleaning validation (ultrasonic technology,
CIP and SIP), Huber STM qualification, vial stoppers study for FDA
commitment, manufacturing autoclave validation (steam sterilization),
packaging line qualification (labeler, cartoner), cleaning development
for the transition of tSB media fill to VPB media fill, aseptical
facilities validation (smoke profile tests, temp. and humidity
studies), VHP isolator, validation for utility systems modifications
(steam, WFI), investigations support, deviations resolution and
technical assessments generation were also performed.
April, 2004 to April, 2005
Eli Lilly - Carolina, PR
QCL Equipment Specialist - Lilly contractor
> Instrument validation (IOQ, PQ) for Quality Control Laboratory (gas
chromatography, glassware washer cleaning validation, water
purification systems, colorimeters, polarimeters, muffle furnace,
refrigerator, HPLC's, dissolution baths, UV). Operational and
Maintenance SOP's verification, personnel training and project
coordination were common responsibilities.
March, 2004 to April, 2004
Ortho Pharm - Manat , PR
Validation Engineer - ESHE contractor
> Microbiology laboratory incubator IOQ.
January, 2004 to March, 2004
Eli Lilly - Carolina, PR
Validation Engineer - ESHE contractor
> QC laboratory glassware washer cleaning validation.
December, 2003 to December, 2003
Pfizer - Caguas, PR
Validation Engineer - ESHE contractor
> Product warehouse temperature and humidity study with Kaye Validator
2000 and humidity dataloggers.
October, 2003 to November, 2003
Schering Plough - Manat , PR
Validation Engineer - ESHE contractor
> Packaging department support and study for product package outsert
misalignment.
August, 2003 to September, 2003
Guidant - Dorado, PR
Validation Engineer - ESHE contractor
> QC laboratory glassware washer cleaning validation.
February, 2003 to August, 2003
Merck Sharp & Dohme - Barceloneta, PR
Validation Engineer - ESHE contractor
> Generated and/or executed Early Technical Assessments, Plant and/or
Equipment Modifications, Installation Completion Records (ICR's),
Installation Qualifications and Operational Qualifications. Performed
commissionings for storage tanks, pumps, filters, instruments and
others. Responsible for the incorporation of equipment and instruments
on the calibration program, maintenance program and spare parts
registration. Performed redmarks for all projects assigned.
April, 2002 to January, 2003
Pharmacia-Pfizer Corp - Barceloneta, PR
Field Engineer - ESHE contractor
> A massive field data gathering was performed for the chemical plant
nitrogen and compressed air systems for P&ID's updating, PFD's updating
and validation support. Process water, breathing air, HVAC and liquid
nitrogen systems were revised in some areas. Collaborated in piping
design projects in chemical plant and finished product areas; also in
modifications for new office facilities, vacuum pumps, reactors and
vent relief piping. Supervised and revised the work done by the CAD
team.
September, 2001 to March, 2002
Merck Sharp & Dohme - Barceloneta, PR
Technology Scientist - Kelly contractor
> Developed API batch records (recipe) to be performed in the process and
cleaning steps for the SPA Project in the Barceloneta facilities. These
batch sheets were frequently discussed with manufacturing plant
operators and safety, environmental, quality and technical operations
personnel. Collaborated in other aspects of the process implementation
and development like mechanical configurations setup, manufacturing
train subdivision, manufacturing troubleshooting support, SOP
modifications and safety concerns like interlocks and psv settings
verification.
June 2001 to August 2001
Bristol Myers Squibb - Humacao, PR
Safety Engineer - CTS contractor
> Performed mass balances for all manufacturing processes
involving hazardous chemicals that were built in BM Squibb
Humacao after May 26, 1992, in accordance with OSHA regulations
(21CFR Part 1910.119).
August to December 1999
Undergraduate Research UPR RUM - Mayaguez, PR
Wine Production from Tropical Fruits - Research
> In search of a high quality wine from the fermentation of
readily available fruits.
SPECIAL SKILLS
> Fully bilingual (Spanish, English)
> Software: Word, Excel, Power Point, Visio, Project
> Experienced in different pharm. areas: Engineering, Manufacturing, Tech
Service and Quality
> Knowledge in FDA regulations, USP, GMP, GEP
> Proven leader and coordinator; excellent team player; used to tight
schedules
References are available upon request
Colina Real, APT 107, 2000 Ave. Felisa R Gautier SJ PR 00926-6645
PHONE: 787-***-**** E-MAIL: ********@*****.***
Contact this candidate