Mechanical Engineer

**** ****** ** **********, ** *****•786-***-****, 561-***-****• rg5t7b@r.postjobfree.com

Nelson Meléndez

Seeking a challenging position in the QA/Validation area where my skills and knowledge can be enhanced in a professional environment. Highly motivated and receptive to other opportunities that would capitalize in experience and knowledge.

Experience

Sept 2008– Present PROCESSO PARTNERS, INC. Miami, FL

MES System Implementation Engagement/Assignment, Phase I

 Work as an IT Compliance Analyst/Business Solution Analyst in the Information Technology Department at Noven Pharmaceuticals, Miami, to implement MES (Manufacturing Execution System)

 Preparing all validation documentation as CSAF, SCQ, URS, SOP, VSD, SRS, IQ, OQ, VP and VR

JDE Citrix and ESX Upgrade Projects

 Preparing all validation documentation as CSAF, URS, VSD, SRS, IQ, OQ, VP and VR

Noven University Modifications Projects

 Due date change and watermark removal activities

 Preparing all validation documentation as SCCR, URS, VSD, SRS, VP and VR

 Execute IQ/OQ/VP

Mar 2007– Sept 2008 STELEX Bensalem, PA

Blazer Process Technology and Validation

 Work as a Validation Consultant at Cordis, Miami, US a Johnson & Johnson Company, to implement another site in Cashel, Ireland

 Preparing documentation as VSD, VP, IQ, OQ, URS, SRS (FS), SOP’s and software categorization

 Travel to Cordis Pilot Plant in Spring House, PA and Cordis Cahel Site, Ireland to perform tests on Binder Vacuum Drying Oven, Mettler Toledo Balances, Terra Universal Desiccators and MPRC (Multi Pass Rail Coater- system with thin client, ACP servers, PLC, and HMI using Wonderware)

 Report project schedule and progress with customer

 GAP Analysis of customer methodology vs vendor documentation

 Support for R&D department for an equipment improvement and operation perspective

Conor Technology Transfer

 Work as a Validation Consultant at Cordis, Miami, US a Johnson & Johnson Company, to implement another site in Cashel, Ireland

 Preparing documentation as IQ, OQ, URS, and software categorization

Jun 2005 – Jan 2007 WEIL GROUP, INC. Caguas, PR

Coating Module Expansion Project Validation

 Work as a Validation Specialist Consultant at Cordis LLC, San German, PR a Johnson & Johnson Company

 Project Team Leader, responsible for supervision of validation specialists performing protocol generation and execution

 Preparing documentation as IQ, OQ, PQ, URS, Technical Reports, SOP’s, and Corrective Action Procedures, Execution of IQ’s and OQ’s

 Clean Rooms Qualification for 100,000 classifications

 Preparing Deviation reports

 Issuing and preparing “Work Orders” as required by Safety in anticipation of the Installation /Operational Qualification exercise

 Responsible for the execution of IOQ activities and preparation of corresponding Technical Reports

 Review and audit raw data, calibration certificates and supporting documentation of IOQ protocols.

 Qualification of equipment as Fume hoods (flow controller, hepa filters, exhaust fans, differential pressure devices), Spray Carts (temperature and humidity controller, pressure indicator, timer, light curtain, rpm controller), microscope

 MES validation execution support with the following functionalities: printing, electronic signatures, electronic procedures, data collection, among other functionalities

 Review spray coating procedure.

 Protocol execution training to technicians and operators.

 Software Installation Protocol execution to spray carts indexer.

Aug – Dec 2004 BAXTER Maricao, PR

Capstone Design Project

 Optimized scrap removal process of Blood Pack Units (BPU) in the Kiefel Machine in order to perform cost-reduction of scrap waste.

 Optimized tab design of Blood Pack Units (BPU) in order to comply with Quality Assurance requirements.

Jun 2003 – Jan 2004 ABBOTT LABORATORIES Jayuya, PR

Engineering Technician II Co-Op

 Create preventive maintenance schedule in most of the equipment of the site for the engineering preventive maintenance program.

 Supervised the Microbiology Laboratory infrastructure remodeling process.

 Designed and supervised installation of an AutoClave Machine.

Education

2005 UNIVERSITY OF PUERTO RICO Mayaguez, PR

Bachelor in Science in Mechanical Engineering, GPA: 3.10/4.00

Skills

 Bilingual (Spanish and English)

 Leadership

 Proactive

 Logical and critical reasoning

 Team leader supervision

 Teamwork

 Goal oriented

 Able to work with minimum supervision

 Ability to work on a fast paced environment

 Computer literate (MS Office)

Activities/Honors

 ITIL Certification

 Project Management Certification

Contact this candidate