Experienced Professional seeking a challenging position in the Commissioning and Validation (CSV) field, focusing on my expertise in utility and process systems Automation and Instrumentation.
QUALIFICATIONS / EXPERIENCE
Over Thirteen Years in Pharmaceutical Industry and Projects Development as service representative, working in engineering design, instrumentation and controllers. Also have been specializing in systems and equipment qualification and GxP validation
• Construction - Strong Experience in Commissioning Engineering, Site Acceptance Test (SAT) and System Installation Completion (SIC).
• Life Cycle Validation Documentation: - Generated and Execution of Validation Protocols (IOQ, PQ and CSV), in addition Functional, User and Design Requirements Specification and Validation Reports.
• Skills - Extensive knowledge in Control and Mechanical HVAC system. Plant Utilities (Chiller, Cooling Tower, Plant/Instrument Air, Portable Water, Heat Exchangers/Hot Water Distribution and Steam/Condensate Systems). PLC, HMI, VFD, Loop Check, Wiring Combination Control Panel, Electrical and Control Diagrams, Instrumentation, Flow and PID’s Redlines Drawing. Electrical Substation Distribution Systems. Furthermore Water System Distribution (WFI, RO, Softener, CDI, UV, Clean Steam, and Skid). Strong experience in Instrumentation and Automation Troubleshooting included interlocks, alarms and functionality. Steam in Placed (SIP) and Clean in Place (CIP) Commissioning and Performance Qualification Execution Protocol. Validator Kaye 2000 study Qualification, Setup, Calibration and Verification including Reports. Performed Filter Integrity Test.
• Personal Background - Strong interpersonal skills, ability to work in a team environment and under pressure with minimum supervision, self-starter, proactive, and responsible. Technical writing and communication skills in Spanish and English. Flexibility in working hours. Interests include traveling and sports.
• Computers - Microsoft Windows, Microsoft Office; Honeywell Excel 500 CARE software, Honeywell Experion software navigation, RS and Control Logix Allen Bradley software; SCADA - Panel Builder, RS View 32, Factory Talk, InTouch Wonderware and DeltaV Distributed Control System (DCA); Cal-Man and Maximo Instrumentation software and Internet Navigation; Visual Basic 6.0, Microsoft Visio and C++, PI Process Book, Validator Kaye 2000 Software.
LICENSE & TRAINING
• E636 Honeywell Excel 500 Controller CARE 3.2 CEU Training Certification (2002)
• Commercial Equipment Electronic Technician Lic. 4138
• Electrical Safety: NFPA 70E Arc Flash Training
• DeltaV Operator Training (Zenith Technologies)
• Syncade Overview Course V1.7
• Programmable Logix Controls (Rockwell PLC 500 /5000)
• Utilities and Process Automation Concepts and Techniques /SCADA
• Good Automated Manufacturing Practice (GAMP)
• GMP’s Instrumentation Certification
• Safeties Training
• Certification in cGXP’s, FDA.s, OSHA’s, ISO 9000, 9001:2001 regulations and guidelines
• FCC’s Marine Radio Operator Permit (1999)
Bachelor Degree on Engineering Science of Electronics
Honors Graduate University of Puerto Rico, Bayamón Campus May 1998
Inter-American University- Bayamón Campus
Current studying Bachelor in Electrical Engineering Currently
PROJECTS & EXPERIENCE
GLOBAL TURN KEY SERVICES – Barceloneta, PR 2009 – Present
Commissioning Qualification & Automation Engineering
Responsibilities consisted in Qualification, Automation and Instrumentation consultant including strong knowledge in HVAC, Plant Utilities and Water System; also field troubleshooting solutions
PROJECTS & EXPERIENCE
Bristol-Myers Squibb (BMS) Large Scale Cell Culture (LSCC) facility ($750MM) located in Devens Massachusetts 2009 to Present
Clean in Placed (CIP) Qualification Protocol Execution
• CIP Large Scale Culture Cell including Media Prep, Buffer Prep, Buffer Hold, Seed & Production (Bioreactors), Purification, Columns Chromatography and Ultrafiltration Skid
• Review analytical results to develop performance qualification (PQ) protocols and release effective circuit
• Water rinsate Sampling of Skids and Glasswashers for analytical testing Release using Bioburden (BIO), Endotoxin (Endo), conductivity and Total Organic Carbon (TOC) under Process Validation
• Visual Inspection and TOC surface swab samples of Process equipment, Vessels, Column-packing, Filter Housings, piping /tubing, pumps, Glasswasher systems, fittings and miscellaneous
Steam in Place (SIP) Engineering Studies and Qualification Protocol Execution.
• SIP Large Scale Culture Cell including Media Prep, Buffer Prep, Buffer Hold, Seed & Production (Bioreactors), Purification, Columns Chromatography and Ultrafiltration Skid. Also responsible to performed Filter Integrity Test.
• Kaye Validator; SIM Thermocouple Installation, Configuration Define Setup, Calibration, Qualification, Post Calibration and Reports.
• PI Processbook Application Graphics and Excel Data Report.
• DeltaV Operator. Fastlook Drawings
• SIP Qualification Execution to 500 Circuits including Biological Indicators (BI’s)
Commissioning Qualification Engineer from Building Automation System (BAS).
• Site Acceptance Test (SAT) and System Installation Completion (SIC) to BAS controller (Factory Talk and Control Logix) from thirty-five (35) AHU’s; in addition Plant Utilities System
• BAS Loop Checks execution (2500 I/O’s points) including Device & Control Net
• Instruments and PLC Panel Installation Verification Checksheet (IC-006) execution
• Control, Flow, Ethernet, Safety Circuit, DeviceNet, ControlNet, and Electrical Power Distribution Diagrams Redlined Drawings; Walkdown to Utilities and Water for Injection (WFI) Mechanical PID’s.
• Installation and Operation Verification (I/OV) execution. Exception Reports (ER) closing resolutions.
• Portable Water, Plant Air, Glycol Chiller, Cooling Tower, Steam & Condensate and Hot Water Systems
• Rockwell and ABB York VFD navigation. Punchlist resolutions
MILLENNIUM GROUP INTERNATIONAL – Guaynabo, PR
2006 – 2009
Automation and Instrumentation Specialist:
Responsibilities in automation (PLC/SCADA) support, instrumentation and CSV generated and execution.
• IOQ (CSV) generated and execution to PLC Water System Controller and Distribution
• PLC Control Panel installation including wiring combination of I/O cards and power supplies
• PLC Rockwell RS Logix 500 software navigation in order to resolve different process and utilities systems
• PLC Generated of Design (DS) and Functional (FS) Requirement Specification
• Honeywell Experion software PLC C200 navigation in order to clears different type of alarms
• Commissioning Documents Execution and Generated also Commissioning Report
MENTOR TEXHNICAL GROUP – Caguas, PR 2004 – 2006
Commissioning Engineering & Validation Specialist:
Responsibilities in generated and execution of Commissioning and Validation Protocols (IQ, OQ and PQ), also controller, instrumentation and process system troubleshooting.
• CSV for DeltaV Automation Software. Design and Software Code Revision
• IQ-OQ and Commissioning CSV execution for Autoclaves systems including PLC Allen Bradley software navigation (RS Logix Ladder) and Delta V /PLC interface
• Instrumentation inventory assessment (Transmitters, Controllers, PI, TI, I/P and Flow Sensors)
• Commissioning and I/OQ to Siemens HVAC control systems in addition Redlined modification As-Built.
• Electrical Power System Substations and Generators, Motor Control Center (MCC) and Plant Utilities
FOSTER WHEELER – Guaynabo, PR 2003-2004
Responsibilities in generated and execution of Commissioning and Validation Life Cycle
• Generated, and Execution of the IQ, OQ and PQ protocol for the Compressed Air System included point of use
• HVAC Metasys Control System IQ/OQ protocols execution (CSV) and Validation Report
• OQ protocols execution for the Honeywell Excel 500 HVAC automation control system
HONEYWELL – Guaynabo, PR 1999 – 2003
Industrial Automation Control Service Representative:
Instrumentalist and controller Service Representative primary responsibilities consisted in maintaining different Honeywell calibration contract for pharmaceutical and medical devices industry.
• Review and generated SOP calibration procedures
• Commissioning and SAT protocols execution to Honeywell Excel 500 HVAC Control System.
• Electronic technologist for Home & Building Project Division
• Provide maintenance and troubleshooting to HVAC & Plant Utility in mechanical & automation control systems
HIGH TECH ENGINEERING – Dorado, PR 1998 – 1999
Field Service Representative
Calibration and certification services of proc