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

Contact this candidate