curriculum vitae ews feb, 2015

ENG. ERICK W. SEPULVEDA LUGO (E.W.S., Inc.)Mobile: (787)-671-8980

Email: [email protected]

I am a Licensed Engineer and a member in good standing of the College of Engineers and Land Surveyors of Puerto Rico with over 18 years of experience as a Project Lead, Validation Lead, Project Manager, Validation Manager and Quality Manager strictly dedicated to Quality and Compliance in the Pharmaceutical Manufacturing, Biotechnology and Medical Devices Industries. I am a Principal Consultant / Subject Matter Expert (SME) for large projects in the Food and Drug Administration, (FDA) regulated environments involving CSV and 21 CFR Part 11 remediation initiatives, among others, at sites in both the United States and Overseas.

Extensive experience working under Consent Decree environments in which the timely implementation of commitments made to regulatory agencies are essential to demonstrate an increased level of compliance with the regulations governing the day to day operations and ultimately assuring business continuity. Active participant in meetings in which strategies for the defense of actions taken by different companies under Consent Decree to increase the level of compliance with the commitments made were developed and successfully executed.

Expert in the development, review, modification and writing of System Development Life Cycle (SDLC) documents.:

Master Validation Plans (MVP) Validation Plans (VP) Installation Qualification Protocols (IQ) Operational Qualification Protocols

(OQ) Performance Qualification Protocols

(PQ) Final Reports (FR) User Requirements Specifications

(URS) Functional Requirements Specifications

(FRS) Functional Specifications (FS) Functional Design Specifications (FDS) Software Module Specifications (SMS) Software Module Design Specifications

(SMDS)

Requirements Traceability Matrices (RTM)

Risk Assessments (RA) Compliance Analysis Gap Analysis 21 CFR Part 11 Compliance

Assessments Remediation Plans Compliance Plans Technical Reports Investigation Reports Standard Operating Procedures (SOP’s) Factory Acceptance Tests (FAT) Commissioning Vendor Audits

Expert in the handling of:

Investigations Corrective and Preventive Action Plans Laboratory Investigations Out of Specifications Investigations Change Control

Non Conformance Reports Audits Commitments Discrepancies Deviations

Expert in the following Building Management Systems:

Staefa Control’s Talon and MS1800 Johnson Control’s Metasys Trane’s TraneSummit and Tracker

Honeywell’s SymmetrE, Plantscape and Deltanet

York’s Facility Manager

Expert in the commissioning, testing and validation of web based applications in FDA regulated environments:

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mailto:[email protected]


Email: [email protected] Laboratory Information Management Systems (LIMS) Trackwise Manufacturing Execution Systems (MES) Documentum Calpro CalManager SAP R3, R6, R6.1, Mercury SAP’s modules for Customer Relationship and Management (CRM), Human Capital Management

(HCM), Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM). Symphony’s Excelence Trough Quality (ETQ) ver. 7 HP Quality Center (Formerly Mercury) Livelink (Document Repository) Signature Server (For the approval of reviewed documents) ERP Systems such as JD Edwards, Censys and PV1 PeopleSoft’s Human Resources Management (HRM) and Customer Relationship Management

(CRM) systems Cognos

Experienced in the following standards:

Information Security Management Standards (ISO 27001) ISO 9001(Quality Management Systems- Requirements) ISO 13485 (Design and Manufacture of medical Devices) ISO 14971 (Application of Risk Management to Medical Devices) ISO 19011 (Guidelines for Quality and Environmental Systems Auditing) PCAOB (Public Company Accounting Oversight Board) created by the Sarbanes- Oxley Act of

2002 Health Insurance Portability and Accountability Act (HIPAA) QSR 820 (Quality System Regulation for Medical Devices) 21 CFR 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or

Holding of Drugs; General) 21 CFR 211 (Current Good Manufacturing Practice for finished Pharmaceuticals) 21 CFR part 11 (Electronic Records, Electronic Signatures) 21 CFR Part 203 (Prescription Drug Marketing)

Experienced Project Manager:

Project Planning Estimating Work Track Project Schedules Track Issues and Budgets Change Requests and Request For Proposals Service Contracts Personnel Supervision Progress Reports Communications

PROJECT EXPERIENCE (Quality Assurance, Consulting and Engineering)

RegeneronAlbany, New York, USA (June 2014- Present)Senior Consultant- Member of the Facilities Maintenance-Manufacturing Department dedicated to the development of System Development Life Cycle Documentation for the Upgrade of the Blue Mountain Regulatory Asset Manager (BMRAM) System implemented on site. This project focused in the resolution of regulatory issues involving various change controls that were implemented and closed with areas that

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Email: [email protected] some clarification and improvement in order to better reflect the actual status of the system and the resolution of pending issues. Some of the responsibilities involve the development of User Requirements Documentation, Functional Requirements Documentation, Technical Evaluation, Risk Assessment, Validation Plan and the creation/ modification of Standard Operating Procedures.

Maquet CardiopulmonaryRastatt, Germany, EU (February 2014 – May 2014)

Senior Consultant – Member of a team of consultants dedicated to the closing of investigation that have been open for more than 6 months following corporate policies and standard operating procedures. This closing is being performed regarding the time the investigation has been open but also in order of priority regarding severity, occurrence and detectability.

McNeil Healthcare LLCFort Washington, Pennsylvania, USA (January 2013 – February 2014)

Senior Consultant – Excellence Thru Quality (EtQ) Dry Runner, Tester and Peer Reviewer for Test Scripts for the Quality Management Systems (QMS) Global Change Control (GCC) and Investigation (INV) modules to be integrated to the client’s SAP system. Dry runner assigned to execute EtQ gap analysis in order to capture areas of improvement to reduce the possibility of defects during actual execution. Also, to verify that all business requirements were met and test steps reflected the actual requirements that a specific step supported, if not, then perform the necessary configuration changes. As a Tester, executed Test Scripts following specific guidelines, SOP’s and GMP’s to ensure the execution complied with all approved procedures and provided documented evidence supporting all the requirements mentioned in the Test Script including the filling of forms, templates and embedding of documents such as PDF and Word. As a Peer Reviewer reviewed executed Test Scripts for appropriate step execution, appropriate documented evidence and GMP compliance.

McNeil Healthcare LLCFort Washington, Pennsylvania, USA (July, 2012 – December 2012)

Senior Consultant – Active participant of the Mercury SAP version 6.1 upgrade project, QM2 and QM3 Hardstop implementation in all phases of the project from documentation and test development to test execution. Part of a team responsible for the clarification of User Requirements and Functional Requirements. Drafting of the User Acceptance Test Protocol and other documents such as Standard Operating Procedures ( SOP’s) required for the system according to business and regulatory needs. Other responsibilities include Development Testing, Functional Unit Testing (FUT), Integration Testing, coaching other team members in regards of Excellence Through Quality (ETQ) functionality and Hewlett Packard Quality Center (HPQC) functionality. Writing, dry run and execution of tests using Hewlett Packard Quality Center (HPQC).

McNeil Healthcare LLCLas Piedras, Puerto Rico, USA (August, 2011 – July, 2012)

Senior Consultant - Part of a team responsible for remediation activities regarding the Consent Decree in which the company is currently under. Direct involvement is the implementation of a Nonconformance and CAPA software named ETQv7.0 in order to replace NEMO (National Event Management Online) System. Direct involvement in the validation of changes required by the client regarding Symphony’s ETQ v7.0. Responsible for giving end user support for ETQ v7.0 ( ETQ Power User) and its interaction with Mercury SAP 6.0. Responsible for giving end user support for MES Pas- X (MES PAS- X Power User). Direct involvement in all the activities regarding the migration from SAP 3.0 to SAP 6.0. Responsible for tracking and reporting of the status of CAPA’s, Nonconformance’s and Action Items status.

Takeda Pharmaceuticals North AmericaDeerfield, Illinois, USA (October, 2010 – July, 2011)

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Validation Lead Responsible for the development of System Development Life Cycle Documentation for a Customer Relations Management tool named Target Suite, which consists of Target Mobile, Target Web and Target Back Office modules. This tool was provided by the vendor Cegedim and will be supported by them to be used by Takeda Pharmaceuticals Mexico. This tool allows Pharmaceutical Sales Representatives (SR) to effectively manage sample information and customer interactions. Other CRM tools or applications for which SDLC Documentation was created are Board 7, IMS- IMS Plus (Performans, PromoTrack, Sales Analyzer and SmartScale), MindGenius, PharmaMix and Physician’s Connect’s Qlikview among other applications. Also part of the team responsible for the Defects Resolution project for Documentum based applications such as SharePoint (SPP). This project consists in addressing defects found in the daily operation of this application documented in various Discrepancy Reports and Change Control Documents regarding the subject. A project which consists of enhancements to the SharePoint application will take place once the defects are addressed. This project will then be followed by the implementation, validation and use DocWay as the new publisher software.

Siemens MedicalMalvern, Pennsylvania, USA (December, 2009 – October, 2010)

Quality Manager Part of a business initiative to integrate business processes and three legacy ERP Systems (JDE, Censys and PV1) into SAP ERP platforms of P40 and P41 in order to create a system landscape that enables the program to achieve One Face to the Customer (OFTC). Responsible for the review of Test Labs during pre-execution and post-execution for completion and accuracy for projects in the areas of Contracts and Leasing, Domestic Order Management and e-Commerce, International Order Management, Service and Complaint Handling, Regional and HQ Finance and Controlling and SRM, and Logistics and Transportation. .Responsible for the update of Test Labs in HP Quality Center, the review of documents uploaded into Livelink and their approval thru Signature Server. Responsible for maintaining Protected Health Information (PHI) according to HIPAA regulation.

Teleflex MedicalChihuahua, Chihuahua, Mexico (May, 2008 – December 2009)

Project Manager responsible for the development and implementation of a Quality System in full compliance with FDA regulations in order to gain access to the United States market. Responsible for the development and review of System Development Life Cycle documentation for all the equipment and systems present on site. Responsible for the coordination of revalidation efforts on existing equipment based on manufacturing schedules and personnel availability. Responsible for updating upper management on milestones achieved on a daily basis and corporate personnel on a weekly basis. Documents include Standard Operating Procedures, User Requirements Specifications, Functional Requirements Specifications, Design Specifications, Requirements Traceability Matrices, Risk Assessments, Change Control Documents, Deviations and Deviation Investigations among others.

LillyGuayama, Puerto Rico (March, 2007 – May, 2008)

Quality Manager in charge of a team responsible for the gathering, review and site delivery of documentation regarding construction activities for the Duloxetine project; which encompass systems such as Water for Operations, Ethyl Acetate Solvent Headers, Toluene Solvent Headers, Nitrogen, Purified Water, Ethyl Acetate Storage and Distribution, Toluene Storage and Distributions, Cooling Water Towers, Process Water, Solvent Recovery Vent Condensers, Waste Water Columns, Recovered Toluene Tanks, Ethyl Acetate Columns, Drying Columns, Reactors, CIP Systems, Milling Systems and many others. Documentation required for these packages ranges from all vendor documentation to As Built PID’s, Weld Maps, Weld Logs, As Built ISO’s, Torque Verification Forms, Continuity Forms, Wiring Diagrams, Loop Diagrams, Slope Verification Forms, Supports Verification Forms, Flushing Verification Forms, Passivation Verification Forms, Pressure Tests Forms, Calibration Verification Forms and others as it applies for each system. All documentation had to be reviewed for completeness, validity, procedure and

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Email: [email protected] Documentation Practices. As part of my duties, I served as a liaison between the Construction team and the Commissioning and Qualification team, the Document Control team, and the Quality Assurance team, also providing expertise in conflict resolution, problem solving and scheduling between teams.

GlaxoSmithKlineCidra, Puerto Rico (February 2006 – March, 2007)

Senior Consultant in charge of a team of consultants with various levels of expertise providing support for the Audit and certification of external software suppliers to GSK Cidra as part of the commitments made to the FDA with the signing of the Consent Decree. Activities included the preparation of communications between GSK and the supplier, confidentiality agreements, schedules, audit materials and reports. Once audits were performed I was responsible for the follow up of corrective actions to be implemented by the supplier, according to GSK policies and procedures. Once the correctives actions were presented, I was responsible for the acceptance or rejection process regarding those actions. Supplier acceptance or rejection was based on the level of quality controls in place. Day-to-day contact with Senior and Director level personnel in order to keep a close look at the performance, roadblocks and areas of improvements, as well as the milestones achieved by the team. In charge of promoting new ideas to senior and director level personnel regarding new approaches to situations that may delay the compliance to dates already committed to the FDA. Provided expertise in the defense of documentation and actions taken by mid and senior level personnel during FDA audits. I was an active participant in meetings in which strategies for the defense of actions taken by the company to increase the level of compliance with the commitments made under the Consent Decree were developed and successfully executed. Additional duties included the development of the System Development Life Cycle Documentation for Fluid Bed Dryers, Powder Transfer Systems, Solution Preparation Systems, High Shear Granulators and other systems for what is called the Granulation 400 project. I was also responsible for the revision of validation documentation for quality assurance purposes and the revision and writing of Corrective and Preventative Action Plans. In charge of developing, reviewing and updating System Development Life Cycle Documentation (SDLC) for Workstation applications and Networked applications for clients located in the Continental US. Documents include User Requirements Specifications, Functional Requirements Specifications, Design Specifications, Requirements Traceability Matrices, Risk Assessments, Change Control Documents, Deviations and Deviation Investigations among others.

Cordis (J&J)San German, Puerto Rico (April, 2005 – January, 2006)

Process Manager in charge of a team responsible of developing all the required System Development Life Cycle documentation (including the Change Control Documents, Deviations and Deviation Investigations) for a custom developed workstation based application with networking capabilities for later integration into MES (Manufacturing Execution System), which is intended to increase the yield in the Basecoat, and Topcoat solution processes areas of production of the Cordis Cypher Drug Eluting Stent. Documentation is being developed as per approved and effective Cordis Computer System’s Methodology and following FDA guidelines for 21 CFR part 11 compliance. Support as requested is also being provided to different business units such as Manufacturing Execution Systems (MES) for validation activities, documents review, and development of test via HP Quality Center (formerly Mercury). Member of the Software Quality Compliance (SQC) team for the review of documentation and member of the Information Management Compliance (IM Compliance) team for documentation review throughout the Cordis organization according the different and varied business needs. I am very knowledgeable of Johnson and Johnson (J & J) Process and Methodologies.

GlaxoSmithKlineCidra, Puerto Rico (March, 2004 – April, 2005)

IT Computer Compliance lead responsible for the oversight for policy and standards application to new laboratory equipment, systems, workstation applications and network applications. Part of a team responsible for the validation of an Enterprise Quality Management System tool (Trackwise). During the

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Email: [email protected] validation I was in charge of the updating of system development documentation such as User Requirements, Functional Requirements and Design Requirements. Also given the task of updating the Master Validation Plan for Computerized Systems as well as the Validation Plan for Trackwise. Served as a point of contact between the client and the software provider to assure documentation provided by the client was up to par with the client’s requirements. Given the task of developing System Testing documentation for Operational and Performance Qualification against requirements, as well as the handling of Change Control Documents, Deviations and Deviation Investigations. In charge of updating data migration, Backup and Restore, Disaster Recovery and System Security Procedures, data migration activities and system retirement. Also responsible for the development of the Validation Summary report. I represented the Laboratory Unit in project meetings related to computer validation, policy design and implementation, change control of computerized systems, automated systems, and applicable remediation efforts. I am also responsible for the review of laboratory requirements, laboratory validation and procedural documents for laboratory database and laboratory database management systems, analytical and microbiological systems, laboratory data acquisition systems, laboratory equipment and utility systems; and to define and communicate to the Quality Assurance Department the Acceptance Criteria for applicable validation documents related to laboratory computerized systems. Quality Manager in charge of a team responsible for the manufacturing and packaging business units to assure compliance with all regulatory requirements; cGMP’s and company procedures, policies and goals. Developed and monitored internal audits to the Manufacturing and Packaging areas. Performed final approval of System Development Life Cycle (SDLC), Change Control Documents, Deviations and Deviation Investigations Documentation for these areas. Identified areas of improvement and made recommendations leading to improve performance, processes and compliance. Directed cross-unit meetings with System Owners of different areas in order to discuss needs and areas of improvement in order to be presented to the Quality Assurance Manager. Met with the Quality Assurance Manager in order to develop strategies to present findings and recommendations to High-Level personnel and eventually presented these findings and recommendations. End result of these meetings was the implementation of these recommendations and the evaluation of steps to follow in order to correct findings.

Avecia Biotechnologies, Inc.Milford, Massachusetts (September, 2003 – February, 2004)

Validation Lead in charge of a team responsible for the development of the Operational Qualification Protocol for the USP Water Generation System and for the USP Water Storage and Distribution System recently bought and installed to increase production capacity from both Equipment and Computer Systems Validations perspectives. This project involved my participation in the review of the Factory Acceptance Test Documents and the Commissioning Documents. I was also directly involved in the troubleshooting of the PLC’s Ladder Logic Programming in order to correct problems in its sequence of operation and in the information provided in the screens of the system that varied from the Functional Specifications of the system. Provide expertise in the actualization of Operational and Preventive Maintenance SOP’s. Reviewed System Development Life Cycle Documentation (SDLC) for Utilities such as DI Loops, PW Loops, Pre-treatment loops (RO Units, UV Lights, Carbon Filters, and Multimedia Filters), Compressed Air, Clean Steam, Plant Steam, Boilers and other equipment for compliance with Equipment Validation and Computer System Validation Standards and Policies as well as for 21 cfr part 11 compliance. Reviewed System Development Life Cycle Documentation (SDLC), Change Control Documents, Deviations and Deviation Investigations for Biotechnology Equipment such as Holding Tanks, Crystallizers, Fermentors, Diaphragm Pumps, Centrifugal Pumps, Agitators and other pieces of equipment. For all cases, Developed documentation when necessary and Executed when necessary. The tool of preference for the development of the tests was Mercury (now HP Quality Center).

Wyeth, Inc.Andover, Massachusetts (June, 2003 – September, 2003)

Validation Lead in charge of a team responsible for the development of all the required System Development Life Cycle Documentation (SDLC) as well Change Control Documents, Deviations and

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Email: [email protected] Investigations in order to comply with IEEE and GAMP 4 Standards for various Depyrogenation Ovens, Glass Dryers, Lyophilizers, Autoclaves, Vial Washers, Filling Lines, Incubators/ Environmental Chambers, Freezers and other pieces of equipment used in the manufacturing of Parenterals. Provide expertise in the actualization of Operational and Preventive Maintenance SOP’s.

Allergan, Inc.Ireland (June, 2003 – September, 2003)

Validation Lead in charge of a team responsible for the development all the required System Development Life Cycle Documentation (SDLC) as well as Change Control Documents, Deviations and Deviation Investigations in order to comply with GAMP 4 Guidelines for various Depyrogenation Ovens, Glass Dryers, Lyophilizers, Autoclaves, Vial Washers, Filling Lines, Incubators/ Environmental Chambers, Freezers and other pieces of equipment used in the manufacturing of Parenterals. I was also responsible for the development of various Standard Operating Procedures for 21 CFR Part 11 compliance, namely Backup and Restore, Archiving and Disaster Recovery procedures. Other SOP’s created were Preventive Maintenance, Calibration and Operational SOP’s.

Boehringer Ingelheim Promeco, Inc.Xochimilco, Mexico (May, 2003 – September, 2003)

Validation Lead in charge of a team providing expertise in Computer System Validation and 21 CFR Part 11 Compliance. Responsible for conducting gaps analyses to various key workstation and networked applications, developing the corresponding corrective action plans. These computer systems included a Laboratory Information Management System (LIMS) Waters Millennium 32, Client- Servers Applications and Stand Alone Applications and BPICS. This evaluation included all the system’s history from the moment of installation up to the present to also correct gaps in their System Development Life Cycle (as well as Change Control Documents, Deviations and Deviation Investigations) and to develop all the corresponding GAMP 4 documentation. Also responsible for the updating of Computer Systems related SOP’s for compliance with the new Risk Based Approach to 21 CFR Part 11 guidelines, now in effect. This was a very time compressed project extremely important for their continuance of importing their products to America; therefore corporate management closely monitored it.

Purdue Frederick Laboratories Inc.Totowa, New Jersey (September, 2002 – May, 2003)

Validation Lead in charge of a team providing support for Computer System Validation and 21 CFR Part 11 Compliance. Reviewing Corporate Quality Guidelines and Corporate Quality Standard Operating Procedures identifying possible gaps, applicable industry practices not being implemented and other Industry Standards. Performing procedural assessments identifying a standard listing of procedures required for the ongoing compliance of the systems, this assessment was conducted against defined requirements. I am also responsible for defining gaps and suggest remediation for those gaps. Review Computer System Validation and conduct Computer System Validation assessments. Providing assistance in determining how systems must be defined. Implementing criticality assessments to define the levels of validation needs. Reviewing how the 21 CFR Part 11 assessments are conducted. Assessing high visibility GxP manufacturing, laboratory and document systems such as PLC, SCADA and MAXIMO Systems, Electronic Documents Management Systems (EDMS) such as Documentum and Oracle, QUMAS DocCompliance and CAPAcompliance systems, Web Content Management Systems (WCMS) such as SAP among others for 21 CFR Part 11 compliance and to determine how remediation activities should be conducted and how CSV and SDLC issues should be solved.

Schering Plough.Kenilworth, New Jersey and Manatí, Puerto Rico (June, 2002 – October, 2005)

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Project Manager in charge of various teams of consultants with various levels of expertise providing support for a variety of efforts to bring equipments, facilities, computer systems and documentation both local and global within acceptable levels of compliance according to commitments made to regulatory agencies. This included day-to-day contact with Senior and Director level personnel in order to keep a close look at the performance, roadblocks and areas of improvements, as well of the milestones achieved, of each of the teams under my wing. In charge of promoting new ideas to senior and director level personnel regarding new approaches to situations that may delay the compliance to dates already committed to the FDA. I was responsible for the re-distribution of personnel according to the varied and changing priorities that came up on a daily basis. I was an active participant in meetings in which strategies for the defense of actions taken by the company to increase the level of compliance with the commitments made under the Consent Decree were developed and successfully executed.

EWS, Inc. Hato Rey, Puerto Rico (Jan. 2002- Jan. 2004)

Director of Operations responsible for the development of all the required documentation to incorporate the Computer System Validation (CSV), System Development Life Cycle (SDLC) and 21 CFR Part 11 approach to the company. This effort includes the development of the company’s business strategies in order to reach pharmaceutical and medical device industries and to strengthen their presence in their client sites. Developed presentations, proposals and CSV trainings for newly hired employees and senior staff. These trainings were based on 21 CFR PART 11 and System Development Life Cycle (SDLC) Methodology. Trainings included the development of all SDLC documentation such as User/ Functional Specifications (URS/ FS), Design Specifications (DS), Traceability Matrices (TM) and Validation Plans among others. Also, trainings included the development and execution of documents such as Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualification (PQ), Factory Acceptance Tests (FAT), Commissioning/ Site Acceptance Tests (SAT) and Vendor Audits. My duties include the task of conducting the interview process for prospect employees to be integrated to the CSV staff. Also, I managed a series of client sites with varying needs and resources successfully.

Janssen Ortho LLC, WyethPuerto Rico (1999-2002)

Validation Lead in charge of a team responsible of the development of Computer Systems Validation documentation for a networked application. The change was made from Millennium Software version. 3.0 To a Millennium Software version. 4.0 And the documentation development for a brand new Millennium version 4.0 application Installation. The implementation of this new software included, but was not limited to, the development of Validation Documentation for the Millennium Client PC’s, Millennium Server and LAC/E Acquisition Servers.

Also responsible for a CSV, SDLC, GMP, GAMP4 and 21 CFR Part 11 compliance assessment of Utilities, Manufacturing Equipment, Networked Applications and Workstation Applications for the entire site, determining the gap between the actual state of compliance and a fully compliant state. This effort consisted in determining the equipment that needed to be Part 11 compliant. The compliance priority of each system and equipment on site was determined via GxP Applicability and Priority filters and CSV compliance assessments. This effort led us to make short term and long-term remediation recommendations for every equipment and system present on site.

PROJECT EXPERIENCE (Engineering Project Manager)

Medtronic, Intel, Embassy Suites Hotel, Marriott Hotel, Ritz Carlton Hotel, Searle, Bristol Myers, Monsanto, Wyeth and others:Puerto Rico and Continental US (1994-1999)

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Project Manager for multiple projects of varying sizes and complexities, from large new constructions to expansion projects with a staff of over 60 engineers, designers, electricians, technical personnel and sub-contracted personnel with their own staff. My main role was providing leadership and supervision in order to complete projects within budget and within schedule, contractor and vendor management. All projects follow local, state and federal regulations, also assuring project documentation control over the life cycle of each project. Also responsible of maintaining good communication with key project players in aspects regarding schedules, schedule changes, budgets, biddings, personnel and many other relevant aspects.

One of my major goals has been the installation, commissioning and start up of various 5000 –plus points Building Automation Systems, which consisted of Air Handling Units of various capacities, Water Chillers, Glycol Chillers, Constant Volume Boxes, Variable Volume Boxes, Cooling Towers of various types, Humidity Sensors, Temperature Sensors, Differential Pressure Sensors, Temperature Control Units and many other pieces of equipment along with the corresponding Building Management Software from many major different suppliers such as York, Trane, McQuay, Siemens, Johnson Controls, Andover Controls, Honeywell, Staefa and many others. Another major goal has been the installation, commissioning and start up of various 3500-plus points Fire Detection Systems from various major suppliers such as Honeywell, Edwards, Cerberus Pyrotronics and many others. Another major goal has been the installation, commissioning and start up of various 1500-plus points Security Access Systems and Closed Circuit Television Systems from various major suppliers such as Andover Controls, Bosch and many others.

Additional responsibilities were the interpretation of specifications and code requirements in order to generate winning proposals, the investigation and development of recommendations regarding engineering projects, the recommendation of applications, systems and equipments according to the needs and the budget of our clients, the development and maintenance of new strategic business relationships to help increment our presence in the research, development and manufacturing industry and the administration of contracts with vendors and service suppliers. Also, I prepared presentations of products, Sales Plans and Business Development Strategies. Other responsibilities were the supervision of service personnel, generation of service contracts, the schedule and coordination of maintenance services, provide technical support remotely or at customer site, the implementation of maintenance processes and procedures, establishing metrics for Quality Assurance of our Service Department to measure customer satisfaction among many others.

PfizerBarceloneta, Puerto Rico (1997-1999)

Project Manager in charge of a large construction project of new facilities and utilities in order to modify current manufacturing areas and expand manufacturing areas as well. This project also required to directly supervise over 60 mechanical and electrical contractors as well as company personnel. Other responsibilities included the supervision of sub-contracted personnel, the field verification of facilities and mechanical construction according to PID’s. Commissioning of facilities and utilities, support to Quality Assurance and Validation personnel. Also in charge of complete instrument installation, verification and calibration. Cost control and schedule planner. I was also in charge of many other aspects as stated above in the summary of engineering experience.

PfizerCaguas, Puerto Rico (1997-1999)

Project Manager in charge of Automation upgrade of existent HVAC Systems and its integration with proposed new HVAC System as well as the Integration of Fire Detection Systems and HVAC Systems. I served as a liaison between Searle’s Engineering Improvers, Mechanical and Construction Teams. I was also in charge of many other aspects as stated above in the summary of engineering experience.

Ritz Carlton HotelIsla Verde, Puerto Rico (1997-1999)

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Project Manager in charge of the construction and maintenance teams of the HVAC, Fire Detection and Suppression Systems, Closed Circuit Video Monitoring and Security Access Systems. Also in charge of the coordination of major construction and maintenance activities, coordination of maintenance and construction teams activities, schedules and budgets. I was the Engineer in charge of Building Management System Software Programming and debugging. I also trained personnel in the use of all systems. I was also in charge of many other aspects as stated above in the summary of engineering experience.

Marriott HotelCondado, Puerto Rico (1996-1999)


Embassy Suites HotelIsla Verde, Puerto Rico (1996-1999)


MedtronicVillalba, Puerto Rico (1995-1999)

Project Manager in charge of the start up of a Large Construction and Building Automation project, along with the installation of a new HVAC system for the new manufacturing facilities. Both systems consisted of more than 5000 points each. Following the completion of the construction projects our team was assigned the task of the calibration of HVAC sensors and monitoring gauges for manufacturing areas and gowning rooms. I was also in charge of the programming of the Building Management System Software. I was also in charge of many other aspects as stated above in the summary of engineering experience.

I was also in charge of developing all the documentation for the Commissioning Activities, Site (User) Acceptance tests and Final Reports.

Following this came the commissioning of the project and the troubleshooting of the entire system, then we gave support for the Validation Activities of the corresponding areas. Validation Activities included Manufacturing Areas, HVAC and Computer Systems. I was in charge of the development of Installation Qualification Protocols, Operational Qualification Protocols, and Performance Qualification Protocols. In charge of the coordination of qualification exercises, studies and execution activities according to pre determined schedules and within pre determined budget.

I was also responsible for the interaction of the Engineering, Manufacturing, QA and Regulatory Compliance Directors for the improvement and approval of the Commissioning Documentation, Site Acceptance Tests, Schedules, Budgets, Validation Protocols and SOP’s.

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Email: [email protected] Piedras, Puerto Rico (1994-1997)

Project Manager in charge of the Installation, Service and Maintenance to HVAC and Fire Detection Systems, Building Management System Software Programming, scheduling of activities on construction and maintenance personnel. I was also in charge of many other aspects as stated above in the summary of engineering experience.

SKILLS / ADDITIONAL QUALIFICATIONS

Computer Software Quality professional, with extensive experience in highly regulated environments.

Expertise in providing guidance in the interpretation of governing regulations to ensure quality policies and practices are followed during all phases of the System Development Life Cycle, including Concept/Analysis, Requirements/Design, Construction/Configuration, Testing/Verification, and Operation/Maintenance.

Established versatility in filling numerous roles on project teams including Project Manager, Project Lead, QA approver, test writer, test executor, test approver, and document author. Constantly seeking and providing guidance to/from fellow team members, regardless of role, in order to foster continuous improvement and alignment with management’s expectations.

Proven ability to adapt and excel in constantly changing work environments and team dynamics while maintaining an objective, open-minded, rational approach. Team sizes have ranged from small high-performance interactive units to a large matrix organization covering multiple projects. Able to manage priorities for long-term project timelines as well as short-term, high-stress efforts in order to meet stringent deadlines.

Excellent oral and written communication, organization, and analytic skills. Able to make informed decisions while keeping in mind both the big picture and the low-level details of a project

Knowledge of OSHA regulations, regarding engineering and electrical construction projects. Experience in developing project proposals, submittals, pricing and its presentations for Control

Systems, Security, Fire Safety and Building Automation Systems. Computer literate, Office XP Professional user. Self-starter, highly motivated, quality oriented individual. Always trying to keep up to date in the latest trends in the Engineering and Quality Assurance Areas. Strong knowledge of CSV, SDLC, GMP, GLP, GDP, GAMP4 and 21 CFR Part 11 concepts among

others. Highly organized with strong attention to detail. Ability to handle multiple tasks simultaneously and effectively. Ability to plan and manage multiple priorities, lead project teams, meet deadlines, and respond

effectively to dynamic situations. Ability to incorporate budgetary and economic factors into designs, and to control costs and meet

budgets.

PROFESSIONAL CREDENTIALSBS in Electrical Engineering, Minor in Electronics and Control SystemsUniversity of Puerto Rico, Mayagüez Campus Licensed Engineer I am a member in good standing of the College of Engineers and Land Surveyors of P.R.Electrical Engineers Institute Member(ASQ-CQE) Candidate Proficient in MS office (Outlook, Word, Excel and Power Point)

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