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XAVIER DE ROJAS SÁNCHEZ THIRD ST. H-15
Electrical and Validation Engineer TERRAZAS DE CUPEY
idolidia@hotmail.com TRUJILLO ALTO, PR 00976
939-397-4726
Willing to travel and relocate
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 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.
XAVIER DE ROJAS SÁNCHEZ THIRD ST. H-15
Electrical and Validation Engineer TERRAZAS DE CUPEY
idolidia@hotmail.com TRUJILLO ALTO, PR 00976
939-397-4726
Willing to travel and relocate
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.
XAVIER DE ROJAS SÁNCHEZ THIRD ST. H-15
Electrical and Validation Engineer TERRAZAS DE CUPEY
idolidia@hotmail.com TRUJILLO ALTO, PR 00976
939-397-4726
Willing to travel and relocate
EDUCATION AND 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
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)
• Ferreteria San Antonio and American Rental Tools (2002-2012)
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
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) 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

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De Rojas Sanchez, Xavier

  • 1. XAVIER DE ROJAS SÁNCHEZ THIRD ST. H-15 Electrical and Validation Engineer TERRAZAS DE CUPEY idolidia@hotmail.com TRUJILLO ALTO, PR 00976 939-397-4726 Willing to travel and relocate 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 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.
  • 2. XAVIER DE ROJAS SÁNCHEZ THIRD ST. H-15 Electrical and Validation Engineer TERRAZAS DE CUPEY idolidia@hotmail.com TRUJILLO ALTO, PR 00976 939-397-4726 Willing to travel and relocate 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.
  • 3. XAVIER DE ROJAS SÁNCHEZ THIRD ST. H-15 Electrical and Validation Engineer TERRAZAS DE CUPEY idolidia@hotmail.com TRUJILLO ALTO, PR 00976 939-397-4726 Willing to travel and relocate EDUCATION AND 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 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) • Ferreteria San Antonio and American Rental Tools (2002-2012) 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 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) 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