Engineer Quality Assurance

Neftalí M. Aguiar Figueroa

**** ****** ***. *** ** Cincinnati OH, 45208 E-mail: *************@*****.*** Cell: 787-***-****

Mechanical Engineer

BSME, experience in Commissioning, Process Development and Validation, Product Impact Assessment for NC investigations, CAPA and Change Controls. Protocol generation, execution, good documentation skills and technical writing reports. Programming and configuring the KAYE Validator 2000 for SIP characterizations protocols to analyzed and monitored, autoclave loads, tanks and warm rooms and cold box temperature mapping. Experience in manual cleaning, and ultrasonic washer validation. Performing FAT and CSV for filler/capper, labeling and cartoner for packaging lines. Hands on Facility and Utilities activities, including, commissioning, inspection and test activities, IQ/OQ/PQ and CSV. Experience on pharmaceutical, industrial and commercial environments. Skills in using a wide range of technical equipment, troubleshooting and business solutions. Design and build mechanical equipment including BMS HVAC, Chillers, Pumps, Cooling Tower, piping, plumbing, Fire suppression system, and Fire alarm systems. Highly motivated, disciplined and resourceful, great teamwork with people from diverse backgrounds. Self- Starter and good verbal as well as written communication skills, Proficient in MS Office and other programs performing quality work complete and on time, according to project schedule.

Jacobs Engineering, C & Q, Allergan, Cincinnati Ohio November/2015 – Present.

Involved in New Product Development, IQ, OQ, PQ, process and cost improvements as commissioning and qualification engineer team. Coordinate with external and internal key person for planning, manufacturing, met regulatory compliance and quality assurance. Ability to make calls with little or no direction based on available facts in order to properly document those decision as part of the project plan and meeting the project goal.

Hands on multi-task on projects while meeting the goal or communicating and follow up the progress for meeting the goal. Ability to design and implement packaging for disposable (sterile barrier) and capital equipment. SolidWorks and AutoCAD skills. Hands-on experience with different types of packaging as bottling, Wallet, cartoners, blisters, vials and syringes. Strong experience in medical device industry.

Ability to develop and execute technical protocols for design verification, process validation, shelf life aging studies, test methods, equipment validation and packaging manufacturing processes.

As part of the commissioning team, coordinate the installation/operational commissioning and qualification execution activities. Write, revise and execute Commissioning and Qualification protocols. Coordinates and/or attends design, construction, and qualification meetings. Coordinate different activities to perform protocols with interdisciplinary staff. Execute and support C&Q activities for IQ, OQ and PQ protocols. I have to support and performing protocols for facilities and utilities using BAS system for HVAC (METASYS by Johnson Controls). Coordinating Walk-down and verification of system drawings. Support discrepancy investigation and resolution of problems and issues encountered during field execution activities. Compile data and prepare reports for completed C&Q activities. Coordinate meetings with project personnel to provide technical advice and to resolve problems. Develops written test procedures; coordinates, witnesses, and documents and or execute functional testing.

Jacobs C & Q Engineering, Lilly Carolina, P.R. 03/2015 – 11/2015.

Commissioning and Qualification, Carolina, P.R., As part of the commissioning team, I established good communication with the design and construction team, understanding commissioning plans protocols. Write Commissioning and Qualification protocols templates. Coordinates and/or attends design, construction, and qualification meetings. Coordinate different activities to perform protocols with interdisciplinary staff. Execute and support C&Q activities for IQ, OQ and PQ protocols interacting with Delta V system. I have to support and performing protocols for facilities using BMS system for HVAC qualification, coordinating Walk-down and verification of system drawings. Support discrepancy investigation and resolution of problems and issues founded during field execution activities. Compile data and prepare reports for completed C&Q activities. Reviews, and provides feedback, RFIs and change orders related to the commissioned systems. Identifies commissioning responsibilities, establishes system boundaries. Contributes to, and supports startup/commissioning safety plans and procedures; assures conformance to company guidelines and practices. Set meetings with project personnel to provide technical advice and to resolve problems. Developed commissioning progress reports for management, client, or others. Develops written test procedures; coordinates, witnesses, and documents startup and functional tests. Develops written test procedures; coordinates, witnesses, and documents startup and functional tests.

RCM Technologies, AMGEN Juncos, P.R. 06/2012 – 03/2015.

Scientist Engineer, San Juan, P.R. Project Location. Role on the project and brief description of project. Protocol generation, execution, documentation, data analysis for reports development with support and resources provided by the engineering department, manufacturing and Quality Assurance departments. Ensures proper GMP documentation with of all test results during protocol execution, analyzing the data and summit the reports. Written technical reports, according to guidelines and procedures from AMGEN Manufacturing Limited. Submitting Product Impact assessments for NC investigations, and technical assessments for CAPA and Change Controls. Prepare and calibrate thermocouples and programming the KAYE Validator 2000 to perform projects of sterilization and/or sanitization for tanks and autoclave loads. Document the characterization protocols. Specialize in characterizations of tanks SIP, Cleaning, Autoclaves loads modifications, Filters Integrity test, pumps and other equipment. Evaluating existing and new equipment for its functional equivalence to be integrated in new process or the replacement of obsolete equipment. Supports the manufacturing activities with characterization, formulation and fill and finish. Lean Six Sigma Yellow Belt certification, access to EDMQ as author, data verifier reviewer and approver and Trackwise access for documentation of NC, CAPA and Change Control.

PHARMA BIO SERV, P&G Cayey, P.R. 4/2012 - 6/2012.

Validation Specialist, Dorado P.R. Writing protocols and technical reports for SOP implementation, as specified by Procter & Gamble guidelines and procedures. Execution of Protocol, with support and resources provided by the Engineering, Maintenance and Quality Departments. Ensures proper documentation of all test results during Protocol execution, data analysis and final reports. Prepare Vendor Acceptance Test (FAT) and Computer System Validation (CSV) Protocol for filler, capper, labeling and cartoner for a production line. Performing and develop a FAT and CSV protocols in Germany for a Groninger filler / capper. Equipment evaluation for Procter and Gamble engineering department. Performing and develop qualification protocols and final reports for Reverse Osmosis (RO) system, Ozone and Oxygen monitors, for Ambient Control system.

MILLENIUM INTERNATIONAL GROUP San Juan, P.R. 11/2011 - 4/2012.

Validation Specialist. Perform and develop validations protocols. Ensure that Protocol is complete, accurate and correctly written, as specified by J&J Ortho Biologics guidelines and procedures. Execution of Protocol, with support and resources provided by the Engineering, Maintenance and Quality Departments. Ensures proper documentation of all test results during Protocol execution, data analysis and final reports. Prepare the Commissioning Protocol, Pre-Certification (if applicable) and Report including the appropriate documentation for test results, calibration reports, deviations, conclusions, and others. Make inspections of facilities construction and equipment installation. Perform the Commissioning test Protocol for a new gowning area and Pre-Weight Room, including Air Balance of the HVAC system, Flow Hood IOQ, Instrumentation Installation and Calibration. Perform the execution of Ultrafiltration / Diafiltration unit, (IOQ) to verify that the unit was installed as specified by OB Johnson & Johnson requirements. Prepare and calibrate thermocouples to perform a Qualification Protocol for a Warm Room and Cold Box temperature distribution with different loads. Programmer a Kaye Validator 2000 to perform protocols execution. Supports all facility activities including, process validations, inspection and test activities.

QUESTUS San Juan, P.R. 1/2011 - 4/2011. Consulting Engineer HVAC consulting Engineer on pharmaceutical environment on Schering Plough in Mexico. Review and verify documents, calculations and drawings specifications. Inspection of the instruments, accessories and equipment installation. Project Supervisor, HVAC air balance, instruments calibration and qualification following drawings specifications. System start-up and troubleshooting. Monitory the areas and adjust the system according to design specifications. Develop several documents as, SOP of the HVAC system, Spear Part List and Maintenance Operation Procedures, Utilities and Facilities qualification. Knowledge of MERCK, FDA, GMP, and ISO guidelines. Supports all facility activities including, process validations, inspection and test activities. IQ/OQ/PQ Train staff in standard operating procedures (SOPs). Improvement of equipment maintenance procedure and active in problems solutions across the plan, train engineering maintenance staff, HVAC controls and technology courses.Calibration Protocols, execution and implementation for Instruments calibration and qualification.

PALL LIFE SCIENCE Fajardo, P. R. / Marcoop 3/2009 – 1/2011. Manufacturing / QC Quality Control- Quality inspection with pressure test and visual inspection to ensure the filters operation and performance. Support all initiatives focus on quality of the products. Active in problems solutions as CAPAs and manufacturing problems investigation. Provide all the documentation and collaborate on investigations and submitted problem solutions. Making measures and pressure test with different calibrated equipment, incoming materials and processing the documentation. Ensure to develop and submit daily reports of the products with a GMP practice.

Quality Assurance Specialist (Injection Molding) Quality Assurance- Inspect the quality of the product and make sure the operators were following the process and specifications. Support all initiatives focus on quality of the products. Active in problems solutions as CAPAs and manufacturing problems investigation. Inspecting the products quality using measuring equipment, material test, incoming materials and processing the documentation. Ensure to develop and submit daily reports of the products, with a GMP practice. Manage and audit inventory accuracy through monitoring of incoming material to verify the authenticity of the material.

AIR CHILLER MECHANICAL, Inc. San Juan, P. R. 1/2005 - 3/2009. Project Supervisor & Sales Engineer. Sales Engineer and Project Manager prepare bids proposal and project development for service of maintenance projects, HVAC system modification on El Nuevo Dia facility site. Coordination project supervisor to install chillers, pumps, piping layout and all its instrumentation. Steel base modification to avoid any structural failure. Manage other similar projects with different clients like: UPR Rio Piedras, UPR Humacao, Dept. de Vivienda, Government municipalities like Carolina, Ponce, Caguas, Departamento de Agricultura and other agencies. Technical support assistance and engineering consultant for industrial, pharmaceutical and commercial clients in all facilities equipment. Projects installation to save energy with controls systems with different clients like: Mc Donald Co., Commercial Industry like Supermarket Mr. Special in Hormigueros and others. Fire alarm system installation (by Honeywell) commissioning and troubleshooting.

PEDRO MEDINA & ASOC. Hato Rey, P. R. 2/2002- 1/2005. Engineering in Training / Design Engineer. Engineering projects related to design and consult HVAC systems, Fire Protection with NFPA codes, sanitary and plumbing design. Project design and development for Hewlett Packard, Hospital San Lucas/ Ponce, Instituto de Ciencias Forences, Government Schools and others. Auto Cad Drawing for HVAC, Fire Protection and Piping systems and its modifications. Consult and coordination of final blueprints modifications for the clients.

Education:

BS in Mechanical Engineering Polytechnic University of Puerto Rico San Juan, PR. 2002

Certifications

Lean Six Sigma, Fire Lite controls by Honeywell

Affiliations

References: Upon request.

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