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Licensed Engineer, Project, Engineering and Validation Manager with experience in the Pharmaceutical, Commercial and Petrochemical Industries. Strong knowledge in Project Management Organization, development & management of site-engineering organizations including Design, Construction, Process, Critical Utilities, Maintenance and Waste Management (under FDA and EPA regulations). Managed Design Office, dealing with clients and preparing BD plans. Improved Maintenance and Utilities departments reducing operation downtime and implementing preventive, predictive and calibration programs. Experienced as Senior Validation team leader for protocols development and execution for Aseptic Areas. Provided Engineering oversight and Project support and to entire manufacturing site (including LPG, Pharmaceuticals, API bulk Manufacturing, Warehousing, Utility and WWTP. US Citizen. Bilingual English and Spanish. Willing to travel.Specialties: Project Process EngineeringEngineering OperationsCommissioning and Qualification ValidationFermentation and Critical Utilities systems Aseptic Area/Clean Room, HVACPackaging, Mixing, Drying & MillingDistillation and purificationWaste Treatment / Effluent Monitoring; Superfund, Aeration Tower, Injection/Extraction WellsOintment, Cream, Liquid and Solid DosageLPG Distribution,and loading station HDPE Extrusion Molding.General Facilities and Electrical Distribution
Cpes
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Engineer, Validation And Project Manager ConsultantCpes Aug 2018 - PresentProvide Technical support and supervision for Electrical and Mechanical Construction Projects. Business Quality review of equipment protocols. Development and proposal origination. Phase 1 Phage Validation Support. Development of commissioning services. Administer subcontractors. Provide as-built drawings and documentation management.
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Principal Engineer And Project ManagerVantage Cg Sep 2013 - Sep 2018Puerto Rico And Us East CoastSerialization and Integration Project Manager-Principal Engineer. Systech (7), Optel (10) and Cognex integration experience.
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Consultant - Process Validation & Project Engineering ManagerDr. Reddy'S Laboratories Under Vantage C.G.; Abbott For Mrs Apr 2009 - Sep 2013Bristol, Tennessee - North Carolina - Puerto RicoValidation of Process and Facilities- CC, VIA, ERES, IOPQ GAP Analysis and Remediation plan. Project Engineering Management.Design and recommend process controls. HVAC and Pressurization Evaluation.Otimization systems operation. Operations troubleshooting and implement design system changes. -
Operations Manager And Chief Process EngineerBe&K Biopharm A Kbr Company Feb 2008 - Apr 2009Delaware And Puerto RicoSuccessfully completed the design of Dupont Tank Farm & WWTP($60MM) at SC. Starting from the selection, training and development of the project team; through its integration as Corporate Design Resources for the $550MM Project. Awarded contracts for design from Key portfolio clients. Timely completion and execution of plan and schedules allowed for increasing responsibilities, being promoted to Operations Manager. Represented the company on Industry and Social events. Coordinated Business Development activities in Interphex, tournaments and other events. Lead and mentor multi-discipline Engineering team, and CAD designers on project work and the development of mission, goal and objectives. Ensured billing cycle completion with review and approval cost, billing, and financial reports. Developed estimates, designs, evaluation of suppliers, clients’ zippering and approved invoices. Obtained 95% approval of all request for corporate release of clients proposals for Engineering and Validation services -
Project/Process Engineering Consultant ServicesBe&K, Pmex Lpg Delivery Facility, Mexico / Abbott, Barceloneta, Pr Aug 2006 - Feb 2008Burgos And Monterrey, Nuevo Leon, MexicoAchieved LPG pumping and Delivery Facility project turnaround in 4 months in Monterrey, Mexico avoiding fines and getting the substantial completion state accepted by client. Successfully overcame the cultural barriers and integrated local Mexican and US designers, supplier and contractors. Developed a trust-based relationship with Customs, government officials and local suppliers to expedite parts, equipment and materials. Executed daily direct local purchases from $5,000 to $25,000. Successfully negotiated and managed local contracts, procurement, expediting, expenses and PCards, Also negotiated the post project inventory liquidation. Avoided costs and fines by executing field design of LPG, I&C, CCTV, electrical, civil, and waste treatment to allow construction crew timely progress. Obtained Client 3P Auditors concurrence on interpretation of the Mexican Electrical Standards vs NEC Code and practices during mediations. Provided guidance and consultation for the design of safety pressure relief systems, Hazops, layouts and cost.
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Engineering Manager - Consent DecreeSchering 2004 - 2006Puerto Rico Met or exceeded all 138 requirements of the FDA Consent Decree Commitments involving facilities, Quality and process improvement projects. Developed and managed the system to train, qualify and certify contractors and suppliers. Dust containment and CIP installation and qualification for tanks and reactors. Managed $45 MM Project Capital Investment annual budget. Developed and maintained a comprehensive 5yrs facilities master plan. Provided oversight and direction to project engineering and technology organizations. Managed 18 services Engineers and 2000 contractors including construction, fabrication and installation. He had zero deviations from compliance with the consent decree and corporate guidelines on FDA, EPA, and OSHA Audits, and Waste Management Area Operation. Reviewed and approved over 400 commissioning, and qualifications of pharmaceutical and API chemical facilities equipment and demonstrated sustainable compliance. -
Area EngineerUpjohn Manufacturing Co. 1981 - 1984Puerto RicoSolid Dosage Manufacturing Technical and Maintenance Support,
Rafael Vazquez Skills
Rafael Vazquez Education Details
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Upr Mayaguez CampusChemical Engineering -
Upr Mayguez, Puerto RicoChemical Engineering
Frequently Asked Questions about Rafael Vazquez
What company does Rafael Vazquez work for?
Rafael Vazquez works for Cpes
What is Rafael Vazquez's role at the current company?
Rafael Vazquez's current role is Engineering, Validation and Project Management Consultant.
What is Rafael Vazquez's email address?
Rafael Vazquez's email address is ra****@****ail.com
What is Rafael Vazquez's direct phone number?
Rafael Vazquez's direct phone number is (212)-733*****
What schools did Rafael Vazquez attend?
Rafael Vazquez attended Upr Mayaguez Campus, Upr Mayguez, Puerto Rico.
What are some of Rafael Vazquez's interests?
Rafael Vazquez has interest in Volleyball, Civil Rights And Social Action, Education, Chess, Human Rights, Golf, Health.
What skills is Rafael Vazquez known for?
Rafael Vazquez has skills like Validation, Fda, V&v, Change Control, Gmp, Process Engineering, Pharmaceutical Industry, Computer System Validation, Capa, Gxp, Quality System, 21 Cfr Part 11.
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