OBJECTIVE:
________________________________________
To obtain a challenging position in the engineer, manager and sales or related field, of a growing company where I can contribute with my skills and acquire knowledge through my work experience for the benefit of both company and myself.
WORK EXPERIENCE:
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October 2013 to Present
Pharma Bio-Serve, Amgen Project /Principal Validation Scientific
Dorado, Puerto Rico 00609.
Description:
• Equipment Validation (IOQ) Protocols Document generation, Preventive Maintenance Checklist, Drawings red-lines for the introduction of the new commercial product (AMG-145) in building AML-01.
• Execution, verification and reviewed of the protocol test results.
• Protocols Report, Traceability Matrix Document and SAT Reports.
• Serialization Project Support, Generation of Commissioning Summary Report and IOQ Summary Report.
• Eisai/Bosch Computer life Cycle Documents, Review URS, Generate Commissioning Plan, Validation Plan, System Design Specifications, FAT Protocols, SAT Protocols, Leveraged Tests, IOQ Reports, Validation Documents Summary Reports (CSR & VSR).
September 2011 to October 2013
Yonkers Industries, Senior Commissioning and Qualification Specialist
San Juan, Puerto Rico 00901.
Description:
• Document generation of Commissioning, System Verification and Equipment Validation (IOQ).
• Commissioning, and Equipment Validation (IOQ) Protocols execution, Preventive Maintenance Checklist, Drawings red-lines, Startup Process of the all utilities (Purified Water, Potable Water, Compressed Air, Nitrogen System, Steam System, Chill Water System, Facilities (GMP Rooms) and Fire Protection System) and/ or equipment (HVAC System) in the New Manufacturing Facilities of Merck Pharmaceuticals in Las Piedras Site.
• Review of the Construction Documentation (CCR’s).
• Project team leader Assistant and management, technical support and coordinator.
April 2008 to September 2011
Pall Life Sciences, Manufacturing Engineer Intermediate.
Fajardo, Puerto Rico 00738.
Description:
• Team leader for Kaizen Group/Lean Manufacturing Process for improvement the process performance in the area.
• Project team leader and management, contractor supervisor, technical support and coordinator.
• Supervisor and assigning work to the maintenance group.
• Generation documents for CAPA’s, SOP’s, Manufacturing Product Order review and approval, Equipment Validation, Process Control Plan for manufacturing area.
• Responsible and Manage Capital Budget.
• Quality Engineer responsibilities, inspection and criteria for acceptance for molding injection components and product.
• Decommissioning equipment, remove equipment from CMMS, Finance Books, Obsoletized SOP’s and Drawing generated and executed a decommissioning document.
May 2007 to April 2008
QRC Group – Biovail Project, Validation/Project Specialist
Caguas, Puerto Rico 00725.
Description:
• DJK Viswill Automated Tablet Inspection Machine Project, Writing documentation as FS, SDS, CVP, SAT and SAT Report, Writing and execution of IQ/OQ and PQ per presentation, IQ/OQ and PQ Report, Troubleshooting and Standard Operations procedures.
QRC Group – Pall Life Sciences Project, Validation/Project Specialist
• Description:
• Easy Label Project, Writing documentation as SDS, Writing and execution of IQ/OQ and PQ, IQ/OQ and PQ Report, Troubleshooting and Standard Operations procedures.
QRC Group – BD Diagnostic Project, Validation/Project Specialist.
• Description:
• Startup Process of the RODI (Process) Water Generation System
• Equipment and Computerized System Validation of the RODI (Process) Water Generation System, IQ and OQ. Protocol writing, execution, verification and reviewed of sampling monitoring results, recommended spare parts list and maintenance procedures. Project team leader and management, technical support and coordinator. PLC Programming in RSLogix Program.
QRC Group – BD Biosciences Project, Validation/Project Specialist
Description:
• Commissioning, Startup Process of the RODI (Purified) Water Generation System
• Equipment and Computerized System Validation of the RODI (Purified) Water Generation System, IQ and OQ. Protocol writing, execution, verification and reviewed of sampling monitoring results, recommended spare parts list and maintenance procedures. Project team leader and management, technical support and coordinator. PLC Programming in RSLogix Program.
• HVAC Qualification Protocol
• Execution, verification and reviewed of the protocol test including the environmental monitoring conditions results, recommended spare part list and maintenance procedures. Project team leader and management, technical support and coordinator.
• Assists in the development of Process Validation Protocols, MSA Study and reports for laboratory equipment.
February 2002 to May 2007
IPR Pharmaceuticals (Astrazeneca), Computer Validation/Process Engineer Associate.
San Isidro Industrial Park Canóvanas, Puerto Rico 00729.
Description:
• Equipment and Computerized System Validation, IQ and OQ. Protocol verification and reviewed. Project team leader and coordinator. CTF 1 Purified Water System validation includes Phase II and Phase III (one year).
• Qualification of IMA Tablet Compression System and packaging equipment. Protocol execution for the Torque and Retorque equipment, Tablet Filler (Lasko) and Induction Sealer Machine, operation procedures.
• Equipment and Computerized System Validation, IQ and OQ. Protocol writing, verification and reviewed. Project team leader and management, contractor supervisor, technical support and coordinator. PLC Programming in RSLogix and builder screens in Panelview Builder 1000 Program.
• CTF2 Purified Water System (Multimedia, Softeners, RO, EDI, Ozone) startup and validation process include Phase I to Phase III).
• IBC Washers startup and equipment/system validation
• Ultrasonic Bath system validation
• Kanebo Automated Tablet Inspection Machine Project, Writing documentation as URS, FS, CVP, FAT and FAT Report, Writing and execution of IQ, OQ per presentation, OQ Report and Addendums, Troubleshooting and Standard Operations procedures.
• Zactima Project
• Utilities Validation activities for HVAC, Process Water, Compressed Air, Purified Water and Facilities. Including IQ and OQ. Protocol verification and reviewed. Project team leader and management, contractor supervisor, technical support and coordinator.
• Equipment and Computerized System Validation, IQ and OQ. Protocol verification and reviewed. Project team leader and coordinator. CTF 1 Purified Water System validation includes Phase II and Phase III (one year).
• Qualification of IMA Tablet Compression System and packaging equipment. Protocol execution for the Torque and Retorque equipment, Tablet Filler (Lasko) and Induction Sealer Machine, operation procedures.
October 1999 t...
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