Enrique "Ricky" Pomales, MSIE, P.E.

Consultant of GEP and CGMP at MTG epomales_1@msn.com

Summary
1.0 "Lo major esta por venir" 2.0 Solo hay area de oportunidades en aquelllos que pensamos positivamente 3.0 Caminante no hay camino se hace camino al andar. 4.0 Salmo 23 Jehova es mi pastor nada me faltara,en lugares de delicados pastos me hara descansar, junto a aguas de reposo me pastoreara, Confortara mi alma, me guiara por sendas de justicia por amor de su nombre, aunqque and en valle de somber de muerte no temere mal alguno , por que tu estaras conmigo, tu vara y mi callado me infundiran aliento, aderezas mesas delante de mis angustiadores, unges mi cabeza con aceite ,mi Copa esta rebosando, ciertamente el bien y la misericordia me seguiran todos los dias de mi vida y en la casa de Jehova morare por largos dias.

Experience
Consultant of GEP and CGMP for Consumer Products at MTG Consultant March 2013 - Present (4 months) Eng. Validation, GEP and cGMP at MTG Consumer products GEP, cGMP Consultant medical device Z at Independent Consultant March 2012 - December 2012 (10 months) Provide GEP/cGMP/Validation Services to Botech/Pharm and Medical Device Sector. Senior GEP, cGMP Consultant at China Institutes of Biological Products at VTI China Office July 2010 - March 2012 (1 year 9 months) Senior GEP, cGMP Consultant at China Institutes of Biological Products Shanghai, Chendu, Beijing Eng. Consultant Haibin Pharm Schenzen China Val Consultant Stryker New Hampshire Val&eng. Consultant VTI China Office Schenzen at VTI China Offfice August 2009 - June 2010 (11 months) GEP @ cGMP Consultant Engineering Consultant for Haibin Pharm Schenzen China C&Q Validation engineer at Genzyme (Validation Urilities) February 2010 - May 2010 (4 months) develop IQ, OQ protocol for Clean Steam generator and execution of Pq for WFI change qualification Automation /Commissioning at Bristol Myers Squibb March 2009 - November 2009 (9 months) Run Delta V text Script trials (Dry runs) for the purification areas. Resolution of automation issues and
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worked closely with Emerson Integrators; Responsible for Delta V Protocol Development\Dry Runs and execution for Lyophilization Equipment and WFI loops . Third Party Engineer at Sanofi Pasteur (Valspec June 2008 - October 2008 (5 months) Responsible for Delta V Protocol Development\Dry Runs and execution for Fermentation and Purification Areas at Sanofi-Pasteur Regular Employee QA Validation Leader at INyx USA January 2007 - June 2008 (1 year 6 months) Responsible for QA validation activities at INyx Site Manati PR. Member of the QS Department team to handle customer complaints, quality assurance, sampling plans and resolve site ICA's in Trackwise. Third Party Engineer at Alexion Pharmaceutical ( Hitachi August 2007 - November 2007 (4 months) for IOQ Protocol generation and execution of Clean Steam Generator, WFI Pilot Plant and Water Pre-Treatment Systems . Commmisioing Lead at Amgen April 2007 - June 2007 (3 months) Leader for the AML-7X (Amgen Project juncos PR.). Develop System Plans, Installation Verification and commissioning Procedures for the equipment and utilities associated to the new Neulasta and Neupogen Purification Suites. Responsible for OQ and PQ protocol generation and execution of pharmaceutical equipment such as Portable tanks including SIP and CIP Phases, Fermentation Wash Autoclave and Refrigerators system at Neupogen Amgen facilities Juncos PR. Responsible for OQ and PQ protocol generation and execution of pharmaceutical equipment such as Portable tanks including SIP and CIP Phases, Fermentation Wash Autoclave and Refrigerators system at Neupogen Amgen facilities Juncos PR. Responsible for equipment/instrumentation receiving reconciliation activities between Procurement and Commissioning and handling closure of discrepancies associated to receiving reports. Third Party Validation leader at Wyeth (WGI August 2006 - March 2007 (8 months) Responsible for IOQ Protocol generation and execution for Solid Dosage Equipment such as Fette Tablet Press, Thomas Engineering Acela-Cota Coater Machine, Alexander roller Compactor at DVS/Viviant Project Wyeth Guayama PR. Provide Computer Validation support for Fette Tablet Press and Alexander Roller Compactor, at DVS/Viviant Project. Third Party Validation Leader at Allergan (WGI June 2006 - July 2006 (2 months) Responsible for commissioning protocol for water pretreatment of vial filling machines Third Party Commissioing Leader at Eli Lilly October 2004 - May 2006 (1 year 8 months)

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Responsible for Commissioning Execution of Purification Skids at PR5 Purification and fermentation Humalog facilities at Eli Lilly Carolina PR. Developed Maintenance and Utilities SOP's to comply with cGMP's and FDA regulations at PR1 Eli Lilly Carolina PR. Provide Computer Validation support for the RPT Phase (3) of Delta V System for PR5 Purification and fermentation Humalog facilities at Eli Lilly Carolina PR. Provide Computer Validation Engineering support for the Qualification of the HVAC system (Metasys Johnson Controls) at PR5 Purification and Fermentation Humalog facilities Lead Validation at AMGEN (As WGI April 2004 - October 2004 (7 months) Lead Autoclave protocol development , execution and evaluation of sterilization criteria for Nepogen component prep and inoculum autoclaves. Regular Employee Validation Project Leader at Schering Plough Regular April 2002 - April 2004 (2 years 1 month) PR Provided validation project management support for the qualification of pharmacy portable tanks projects, HVAC and Refrigerators qualification, document backlog and Exception/Deviations Back projects, Icos, Amsco Washer and Mar filler related to Celestone project at Schering-Plough Manati, P.R. Responsible for PQ protocol generation and execution of aseptic pharmaceutical processes such as autoclave (Amsco) sterilization cycles, Oven (Lydon), Tunnels depyrogenation, sterilization cycles .Also supported requalification of the Steam in Place sterilization process on SIP Tanks, portable pumps and mills. Third Party Engineer at Bristol Myers April 2000 - April 2004 (4 years 1 month) Responsible for IQ/OQ protocol generation and execution of pharmaceutical equipment such as Accela-Cota Coating Machine and Fieldmeir Solution Tanks, High Shear Mixer (Niro-Aeromatic-Fielder), Safeline Metal Detector, Kikusui Multitesters and Dedusters, Nitrogen and Compressed Air Pipe extensions at BMS facilities Engineer at ATT-Lucent (Regular April 1996 - April 2000 (4 years 1 month) Prepare test validation protocols for Central Office Voicemail system (CO ACCESS) and Converse Technologies. (1999) ATT New Jersey Lucent Technologies- Implemented statistical process control techniques (SPC), process capability, design of experiments (DOE), manufacturing simulation on surface mount processes such as screen printing, Seiko robots, electrovert reflow ovens and Panasonic placement machines. Engineer at Lucent Technologies January 1996 - January 1999 (3 years 1 month) Motorola- Process engineering applied to SMT Technologies as well as wave soldering process, procees capability and design on experiment appied to Screen printing, and machine placement. (Motorola PR 1995)

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Publications
Air Breaks on Class A nd B in GMP environments VTI Authors: Enrique "Ricky" Pomales, MSIE, P.E.

Courses
MSIE, Industrial Engineering New Jersey Institute of Technology Advance Design of Experiment Advance SPC (statistical Process contol)

Projects
Shanghai Institutes of Biological Technologies January 2010 to March 2011 Members:Enrique "Ricky" Pomales, MSIE, P.E., Jonathan Woodburn, Ed Winnett, Honey David, David Vincent The Chinese people are one of the most culturally riched in the world. To learn English for them is so proud and a path to move upscale the ladder. Most of the signs in the major cities are bilingual mandarin and english. It is was so good for me to work with them. I learned how wrong are most of us in america about them. Those who have dish please take a look at channel 265 CCTV news. This is like a competitive network in english ran from Beijing globallly for CNN but with another perpestive with sites in London, Eashington DC and Africa). Sometimes we need the other perpective to be able to make a good judgement. Ricky

Languages
English Spanish (Full professional proficiency) (Full professional proficiency)

Skills & Expertise

Process Validation cGMP Validation Commissioning Life Sciences

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Lifesciences GMP FDA Design of Experiments Quality System Quality Assurance Manufacturing V&V 21 CFR Part 11 Sop Computer System Validation Process Engineering Aseptic Processing CAPA GxP GAMP Change Control Engineering Cleaning Validation Medical Devices Technology Transfer Pharmaceutical Industry Biotechnology Sterilization Biopharmaceuticals Trackwise ISO 13485 Quality Auditing Regulatory Affairs Pharmaceutics Automation SPC GLP ISO Process Simulation LIMS Quality Control Vaccines FMEA Root Cause Analysis Software Documentation Regulatory Requirements HPLC GCP Clinical Trials

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Education
New Jersey Institute of Technology MSIE, Industrial Engineering, 1996 - 1998 New Jersey Institute of Technology Master, Science Industrial Engineering, 1996 - 1998 University of Puerto Rico Bachelor, Science Industrial Engineering, 1990 - 1995

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Enrique "Ricky" Pomales, MSIE, P.E.

Consultant of GEP and CGMP at MTG epomales_1@msn.com

Contact Enrique "Ricky" on LinkedIn

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