Key Competencies
Validation
FDA Regulatory Requirements
Validation Documentation System
Risk and Impact Assessment
CSV / Automation
IQ/OQ/PQ
Experience
Lilly Del Caribe (Commissioning Agents)
Puerto Rico
Amgen (Kelly Services)
Juncos, PR
Validation Engineer
Duration of Assignment: Ongoing Since April 2014
Decommissioning and Commissioning for the Expansion of the Water Waste Treatment Plant with MBR and Odor Control System.
Decommissioning and Commissioning for the Emergency Generator System.
IC, OC and Decommissioning Protocol Development-Development of Critical Validation Tests
Development and Handling of Deviations and Investigation Reports, Final Report and Protocol Package Generation
Execute Decommissioning, IC and OC Protocol after Development
Execute RV and IV manually and using Data Voke program.
Subject Matter Expert and training support on Data Voke program.
Associate Manufacturing
Duration of Assignment: 1 Year
Startup of the building AML-14 in the Filling area.
Under general supervision, performs manufacturing processes according to Standard Operating Procedures. Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures. Perform and monitor critical processes.
Execute routine validation protocols. Comply with GMPs. Regularly draft and revise “routine” documents (e.g. MPs, SOP’s, and technical reports). Initiate Quality incidents.
Identify and recommend improvements related to routine functions and implement after approval. Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records). May train staff to perform hands-on tasks.
Basic troubleshooting. Recognize & accurately report problems. Direct operator on critical processes using SCADA and HMI.
May act as safety representative. May assist with system ownership responsibilities.
Gvelop
San Juan, PR
Energy Auditor
Duration of Assignment: 1 Year
Load analysis in different dwelling units throughout Puerto Rico, in order to determine if it is necessary to optimize the energy efficiency.
Organize and manage documentation of project design for client submittal.
Carry out team meetings in a weekly basis for progress reports and discuss pending issues in order to organize them in a chronological manner.
Ferreteria San Antonio and American Rental Tools
San Juan, PR
Sales/Rental Representative
Duration of Assignment: 10 Years
Company sales and rentals representative for different Puerto Rico construction companies.
Manage and deliver promotional messages of different products in order to maintain an effective sales flow. Manage and train renter for proper use of equipment.
Programming of cash register. Manage marketing budget.
Assure that business goals are accomplished as establish by upper management.
Manage product inventory for stock availability. Licensed finger lift operator.
Academic Project
Puerto Rico
Team Leader / Smart Car Seat
Duration of Assignment: 6 Months
Designed an electronic car seat that alerts the parents, through a text message and a buzzing and flashing alarm, when a baby is left inside of the vehicle.
Assigned tasks to team members in order to:
Gather thorough information of the theory and equipment necessary for the completion of the project.
Separate the whole project in stages.
Verify the completion of the design progress of each stage of the project.
Built the electronic circuit design with Arduino UNO microcontroller board hardware.
Developed the microcontroller software through Arduino 1.0.1 software.
Academic Project Lord Electric Co.
Puerto Rico
Team Member / LEED Certification of an existing building
Duration of Assignment: 3 Months
Conducted research about the concept of a LEED Building.
Selected an appropriate sustainable site, in our case the LORD Electric CO. building.
After selecting the site, made an electrical load analysis of the building, water efficiency, reflective capacity of solar irradiation, hybrid cars parking slots and areas of interest to plant some trees.
Complied with LEED certification point chart in order to gather the most possible points.
Academic Project
Puerto Rico
Designer / Automated Three Level Elevators
Duration of Assignment: 3 Months
Performed Automation of an elevator that sorts three different levels using a Programmable Logic Controller (PLC).
Designed Software of the PLC that controlled the main control which is composed of two stations:
The first station works with the inside elevator control
The second station works with the outside elevator control in every floor.
Between doing the two control stations, was also working with all the security parameters.
Complied with the costumer’s requirements in the programming process.
Education & Certifications
Education:
BS, Electrical Engineering, Polytechnic University of Puerto Rico (ABET Accredited) Graduated May 2012
BS, Electronic Engineering Technologist, University of Puerto Rico Graduated May 2008
Certifications:
Validation Industry
Photo-voltaic Systems Installer
History & Training
History:
BS, Electrical Engineering, Polytechnic University of Puerto Rico
BS, Electronic Engineering Technologist, University of Puerto Rico
Commissioning Agents, Validation Engineer (2014-Present)
Kelly Services, Associate Manufacturing (2013-2014)
Gvelop, Energy Auditor (2012)
Training:
FDA Regulatory requirements and Validation Documentation System
User Requirements, Functional Specification, Impact Assessment, Risk Assessment, Traceability Matrix and Validation Plan
IQ, OQ, PQ Protocol Development-Development of Critical Validation Tests
Development and Handling of Deviations and Investigation Reports, Final Report and Protocol Package Generation
Data Voke program support
CSV / Automation
Packaging Validation Considerations in the Healthcare Industry
Pharmaceutical Water Systems Monitoring
Cleanroom Regulations & Monitoring
Rockwell Automation Studio 5000 Logix Designer: ControlLogix Fundamentals and Troubleshooting
Skills
Fully bilingual: English and Spanish
High-energy, results-oriented employee and team builder with excellent leadership and interpersonal skills
Emphasize quality and company success through communication, process development and improvement, productivity enhancement and cycle time reduction
Microsoft Office oriented: Word, Excel, Power Point and Publisher
Knowledge in the use of AutoCAD, Visual Basics, PSpice, Arduino and MatLab
C++ and PLC (RS Logic and Studio 5000) programming language oriented
Able to work independently according to business requirements.
Multi-tasking oriented. Strong mathematical knowledge and skills
Basic knowledge of Project Managing
Knowledge of CSV and Automation