SummaryLooking for an Engineer Engineering position 2 YEARS Food Industry providing guidance on FDA new regulations FSMA. 2 YEAR hands on FANUC Robots - PALLET TOOL BS in EE MS Engineering Mgmt. (25 Completed) with 8 years of engineering experience 3 YEARS on Critical Utilities Project Management - performing Power Distribution System Feasibility Studies to retrofit critical High Voltage equipment as part of a pilot project to develop a more ROBUST and RELIABLE Power Grid Infrastructure Design a centralized UPS to provide redundant power to a HPLC lab to reduce the risk during Voltage fluctuations Design and implement a Power Quality Management System to continuous monitoring the incoming power from Utility company Design a SCADA to monitor the complete Power System Grid including the following equipments, but not limited to Backup Generators, UPS, Main Switch Gears, ATS and Main Distribution Panels. Develop a Reliability Program to provide power redundancy to all critical Utility Systems such as (Boilers, Clean Stem Generators, UV Light System and Reverse Osmosis). Conduct a Grounding and Bounding Feasibility Study to facility in order to ensure employees SAFETY. 5 years of hands-on PLC, HMI, SCADA for DCS and BMS - Wonderware, iFix, iBatch etc programming experience including Siemens S7, ControLogix, SLC500, SLC 5, Logix5000. Expertise with ISA 88 Batch standards Experience with SQL database used for data-logging and reports at Wyeth. Commissioned and started up solid dosage Niro atomizer at Janssen, Puerto Rico as a system integrator 2.5 years of Automation Project engineering experience with PLC SCADA for critical power monitoring system. Handled complete project cycle including customer requirements, estimating proposal support, functional system spec development, customer approval process, control panel hardware design, review P ID s , field instrumentation specification selection, in house FAT with customers, site commissioning and startup assistance, validation support as needed, final training and documentation support 5.5 years of BioPharma Industry experience with production support and troubleshooting. Supported multiple shift production environments at Pfizer, Wyeth, Janssen and Baxter 2 years of Control System Validation experience with IQ, OQ protocols and cGMP Regulations Extensive experience on Control System Designs including hardware, Electrical Panel Design and Field Instrumentation Excellent team player. Work well with management, vendors, contractors and production personnel. Ready to relocate QUALIFICATIONS Analytical and skilled Controls System Automation Engineer with a background on pharmaceutical manufacturing process with management experience and Power Systems project management. Regulations Compliance Expert specializing in cGMP s, OSHA, and FDA regulation compliance. Analyze plant, manufacturing and equipment needs. Develop most economic and cost-effective methods specialize in facilities design and work measure and methods. Proficient in enhance return of investment. Engineering Methodology Skills include develop, evaluate and implement cost-effective equipment s to ensure that GMP facilities and biotechnology environment meets all regulated agencies compliance. Also include Automatic Equipment troubleshooting, Emerson Delta V, Rockwell Automation RS Batch, RS View, RSLinx, Allen Bradley Device Net, Allen Bradley Variable Frequency Drives, PID Controller Tuning, SCADA and HMI Design (Wonderware, iFix, RSView, Insight), Ladder Logic (PLC) interpretation development as well as P IDs interpretations analysis. Knowledgeable in Sterilization Process, Filling Machines, Vial Washers, Sterilization Tunnels, Cleaning in Place, Pressure Test, area models for Batch recipe processes. continued. AMIR E. Claire SOTO - Page Two - Project Management Excellent skills in project coordination, team leadership, process improvement, as well as technical engineering project deployment and reliability. Skilled in unearthing data and translating complex information into clearly understandable language. Cost Consciousness - Works within approved budget Develops and implements cost saving measures Contributes to profits and revenue Conserves organizational resources. Dependability - Follows instructions, responds to management direction Takes responsibility for own actions Keeps commitments Commits to long hours of work when necessary to reach goals Completes tasks on time or notifies appropriate person with an alternate plan. Initiative - Volunteers readily Undertakes self-development activities Seeks increased responsibilities Takes independent actions and calculated risks Looks for and takes advantage of opportunities Asks for and offers help when needed. Judgment - Displays willingness to make decisions Exhibits sound and accurate judgment Supports and explains reasoning for decisions Includes appropriate people in decision-making process Makes timely decisions. Organizational Support - Follows policies and procedures Completes administrative tasks correctly and on time Supports organization s goals and values Benefits organization through outside activities Supports affirmative action and respects diversity. Planning Organizing - Prioritizes and plans work activities Uses time efficiently Plans for additional resources Sets goals and objectives Organizes or schedules other people and their tasks Develops realistic action plans. Problem Solving - Identifies and resolves problems in a timely manner Gathers and analyzes information skillfully Develops alternative solutions Works well in group problem solving situations Uses reason even when dealing with emotional topics. Professionalism - Approaches others in a tactful manner Reacts well under pressure Treats others with respect and consideration regardless of their status or position Accepts responsibility for own actions Follows through on commitments. Project Management - Develops project plans Coordinates projects Communicates changes and progress Completes projects on time and budget Manages project team activities. Quality - Demonstrates accuracy and thoroughness Looks for ways to improve and promote quality Applies feedback to improve performance Monitors own work to ensure quality. Safety and Security - Observes safety and security procedures Determines appropriate action beyond guidelines Reports potentially unsafe conditions Uses equipment and materials properly. SkillsJava, C , Excel, Power Point, Word, Word Sampling, Visio Studio, and AutoCAD other skills include Allen Bradley PLC programming and troubleshooting, PLC5, SLC500, ControlLogix 5000, DCS, BMS and Data Historian Systems programming and configuration, familiar with Intellution Fix32, Wonderware environment, Foxboro AW, Siemens Insight installation and configuration knowledge. Some knowledge of MSDE manager - SQL Datalogging and reports. Assesses own strengths and weaknesses Pursues training and development opportunities Strives to continuously build knowledge and skills Shares expertise with others. ExperienceElectrical Automation Maintenance Engineer,08 2013to11 2014Marriott International Marco Island,FL,Responsible for developing, evaluating and implementing cost-effective power quality equipment, facility and utility engineering projects that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment.This includes all phases of the project including conception, developing justification, presenting to management, preparation of the capital request, budget management, project timeline creation and management, detailed design and vendor contractor scopes-of-work (RFQs RFPs), competitive bidding, placing purchase orders, contractor and consultant supervision, installation, commissioning, debugging, optimization, supporting Validation and training maintenance and manufacturing personnel.In addition, responsible for providing day-to-day technical support for manufacturing issues that arise including troubleshooting equipment and systems as well as supporting investigations.Upgrade the facility Power Distribution grid by segregating manufacturing bioscience suites to be independent on power source to allow PMO to perform shutdown projects independently without affecting or compromise business and implement redundant power source to feed loads.Design and implement a Power Quality Management System to reduce equipment s failures and reduce NCR s or PR during power interruptions.Design and create a network infrastructure to add all power distribution equipment s on LAN and perform in an easy and Automated Preventive and Corrective Maintenance.Equipment s such as UPS, Power Generators, Automatic Transfer Switch, VFD s and Main Switch Gears.Modify and upgrade SOP to align them with the technician s execution to be in compliance with regulatory agencies.Including PPE requirements to comply with OSHA.Identify power system deficiencies and vulnerabilities in less than 2 months of work, design and implement cost effective solutions to cover the existing gaps in the power distribution grid.Reduce department WO and PM backlogs within less than 3 month finalized numerous projects to completion, led a migration of a human machine interface application for freeze dryers and installation of an AW for the Foxboro control environment of the aseptic area during company shutdown.Incorporate Laboratories equipment into a monitoring system to detect any failure during process and provide fast response.Successfully upgrade the entire pneumatic tubing system of the Fill Line including Vial Washer, Sterilizer Tunnel, VHOP Isolator and Fill Line in a 100 rating of backups for PLC s and HMI computers tuned a PID on a PLC for the optimization of a process.Reduced and eliminated bottlenecks in manufacturing, improving space utilization metrics.Updated and ensured the on-going data processes and maintains process documentation.Acted as the primary point of reference for questions, problems, and suggestions.Investigate and analyze customer problems then create Reliable improvement recommendations.Oversee all work performed including preventative, corrective, calibrations, automation changes and Engineering change requests.Able to contribute to cost estimating of major capital budget items and control spending of approved project funds.Create Life Cycle documents (functional specifications, design specifications).Create and modify SOPs for utility systems and automated process systems.Project Manager,11 2012to01 2013MILLENNIUM MAINTENANCE ,,Electrical Project Manager for construction projects develop by contractors in Manhattan and Brooklyn.INDEPENDENT CONTRACTOR,01 2012to05 2012AMIR E. SANTIAGO SOTO ,,Professional Service to Pharmaceutical Industries Perform as Automation Consultant for Pfizer Carolina and Guayama site, Janssen Gurabo, Merch Las Piedras.Provide consulting services for systems integration, new equipment s installation, start-up and computer systems validation.Also provide recommendations during FAT.PFIZER, CAROLINA, PUERTO RICO APRIL 2011 MAY 2012 Professional Service as Metrology Standards Controller Perform as controller to the site Calibration Standards Off Site calibration logistic.Assure that every standard be sent for calibration 60 days before due date in order to be in compliance and keep the stock up to date on instrumentations.Conduct MIR on every Out of Tolerance condition in order to evaluate the possible product impact by performs a Reverse Traceability on the Calibration Standard Manager CALMAN .Provide costumer service when required for any field support during manufacturing.Provide support to Technology IQ, OQ and PQ when required.WYETH-AYERST LEDERLE, CAROLINA, PUERTO RICO MARCH 2006 NOVEMBER 2009 Instrumentation Process Controls System Engineer II Conduct extensive troubleshooting, maintenance, configuration and monitoring of various manufacturing equipment, packaging and utilities in compliance to cGMP procedures.As part of a critical 10-member team, oversee and lead all areas of Automation, Process Engineering and Systems Engineering.Train, Manage and mentor operators and mechanics in company SOPs.Drive and evaluate technical concepts to verify optimal operational effectiveness.Manage and allocate resources ensure timely project deliverables.Assess and evaluate the integration of all manufacturing control systems to a central Uninterruptible Power Supply system (UPS), conduct load analysis for cost reduction project to reduce a 40 the energy consumption, electrical equipment damage prevention, and process improvements.Perform as a leader on an experimental project for an aseptic area Filling Machine Lines to avoid the vials falling during manufacturing, in order to reduce the production hours and obtain a better machine performing as an Instrument Control System Engineer.Finalized numerous projects to completion, led a migration of a human machine interface application for freeze dryers and installation of an AW for the Foxboro control environment of the aseptic area during company shutdown.Incorporate Laboratories equipment to a monitoring system to detect any failure during process and provide fast response.Conceptualized, planned, and introduced a stopper processor machine (Huber) that utilized silicone emulsion for the dosing, recommended and successfully implemented a direct silicone dosing for the process.Successfully attained a 100 rating of backups for PLC s and HMI computers tuned a PID on a PLC for the optimization of a process.Reduced and eliminated bottlenecks in manufacturing, improving space utilization metrics and increasing resource allocation optimization.Updated and ensured the on-going data processes and maintains process documentation.Acted as the primary point of reference for questions, problems, and suggestions.Assembled and maintained change and problem history records prepared statistics and trend reports.Collaborate on the implementation of OSI PI Data Historian system.Dramatically increased department productivity by reducing down time of manufacturing equipment.Leader of a technical project on an aseptic area vial filling machine to perform the reduce of falling vials during manufacturing.Perform as a project leader on a SCADA upgrade from iFix 32 to iFix 4.0 platforms for Freeze Dryers systems and also for BOSCH filler machine using Wonderware.Upgrade site SIEMENS BMS platform by incorporate DCS system to site network.Reduce external sub-contracts by performing and develop most of the sub-contract activities such as BOSCH Filler TPF computer replacement and startup, Siemens BMS computers rebuilding and reconfiguration.Electrical Installation Assistant,01 2004to01 2005JUAN F. GARCIA INC City,,Puerto RicoProvide technical support on electric project at Carraizo Dam, Trujillo Alto, and Puerto Rico.  SEP  Business Analyst Location Remote.Duration 12 months.MOI Skype About the RoleThe Business Analyst will support a cross-functional project teams focused on driving the end-to-end digital product lifecycle for features and products to improve the overall online experience of residents and businesses in the State of Connecticut. The Business Analyst will support one or more teams by performing detailed requirements analysis, create and maintain relevant productproject documentation, and perform solution testing consistent with the goals and objectives of the Connecticut Digital Service. Experiences Required for This Role Requirements Analysis At least 5 years of experience and use cases with the following Evaluating business processes and user needs Anticipating requirements, uncovering areas for improvement, and developing and implementing solutions Effectively communicating your insights and plans to technical and non-technical audiences, including cross-functional team members, stakeholders, and management Prioritizing requirements based on product roadmap, business needs, and technical feasibility Ability to navigate complex stakeholder relationships, competing resources, and prioritiesRequirements Documentation At least 3 years of experience and use cases with the following Conducting meetings and presentations to share ideas and findings Documenting results of your requirements analysis in the format of user flows, system flows, system requirements, user stories, and user acceptance criteria Gathering, documenting, and reporting critical information from meetings with various stakeholdersUser Acceptance Testing At least 2 years of experience and use cases with the following Ensuring solutions meet business needs and requirements Performing user acceptance testing Classifying and documenting defects Digital Platforms, Tools and Discipline At least 2 years of experience and use cases with the following Working with enterprise scale digital platforms specializing in at least 3 omni-channel service delivery, web content management, customer relationship management, identity and data integration Establishing continuous improvementdelivery pipeline to continually improve products post-launch based on customer research and feedback Using of productivity, communication and analysis tools to manage iterative delivery, such as JIRAConfluence, Google Analytics, Git Repository, Microsoft Teams, Microsoft Office (Word, PowerPoint, Excel) Staying up to date on the latest process and IT advancements to automate and modernize systemsKnowledge, Skills, and AbilityBusiness Analysis Exceptional analytical and conceptual thinking skills The ability to influence and determine acceptable solutions with stakeholders Advanced technical and documentation skills Fundamental analytical and conceptual thinking skills Reporting and presenting A track record of following through on commitments Excellent planning, organizational, and time management skills A history of leading and supporting successful projectsPerformance in Complex Situations Communication and collaboration with state-wide partners Clearing challenges for team member Judgement fitting to the ever-changing environment Ability to juggle multiple project workstreams Service Design Team Building Supporting teammates skills and behaviors development and delivery A balance between strong domain expertise and flexibility Judgement in dealing effectively and diplomatically with all levels of government staff