Technical Expert / Project Manager
Resume:
E-mail: *************@*****.***
ANGEL A. VEGA, PE 14304
SUMMARY
For over 20 years, have been leading technical teams to assure reliable equipment and process in Pharmaceutical Operations as well as compliance to applicable regulations. Among the most remarkable achievements are: driving a culture change implementing Lean Manufacturing across a manufacturing site, Improve critical equipment reliability, increase manufacturing / packaging processes available time and elimination of process defects. The experience includes the technical support to process related to: granulation, blending, tablets compression and coating, capsules filling, suspensions preparation and packaging of blisters and bottles with vision systems for inspection of labels and printing. The activities executed includes: troubleshooting of systems, interaction with quality operations to document all events related to manufacturing batches, Investigation of non-conformances and deviations, CAPA management and customer complaints. All these using the lean sigma tools. During the process I have developed knowledge in quality systems to document changes to equipment and systems. This includes: risk and cleaning assessment, qualification protocols, SOP and training. As additional roles during my career have executed key roles in the implementation of strategical projects for the organization like transfer of new products and the validation and start up of a new manufacturing suite. Also, have been named as SME for Maintenance, Calibrations, Facilities Design and Utilities Quality Systems. All these experience have help to develop a strong technical skills and broad knowledge of Equipment Reliability, Process Improvements and regulations to be in compliance with GMP, Safety and Environmental.
EDUCATION
BACHELORS DEGREE OF SCIENCES, ELECTRICAL ENGINEERING
University of Puerto Rico, Mayagüez Campus
COMPUTER SKILLS
BAS, SAP, MAXIMO, MIDAS, DCA, Autocad, Mini tab and Microsoft Office.
SKILLS
LICENSED ENGINEER (CIAPR) PROCESS INVESTIGATIONS
RCM FACILITATOR MANAGEMENT OF CHANGES
TOYOTA KATA COACH EQUIPMENT VALIDATION
SMED TRAINER PACKAGING INSPECTION SYSTEMS
VFD AND PLC APPLICATIONS SOLID DOSE MANUFACTURING
NFPA 70, 70E RISK ASSESSMENT
LEAN SIGMA PROJECT MANAGEMENT
EXPERIENCE
FITS, INC.
Manati, PR
Project Manager
August 2016 – May 2017
oAssure design of Hygienic Utilities (WFI, Clean Steam, Air, Nitrogen) comply with company specifications. Approve drawings and components recommended by designer
oSupervise construction and installation of Hygienic Utilities Systems and HVAC
oPerform systems start up and recommend fine tuning for operational parameters
oDesign process for WFI tank and loop sanitation
oDevelop solution for non-conformance conditions identified including documentation of changes
oApprove contractors Turnover Packages
oAssure all systems SAT, IOQ and PQ were executed
oPerform investigations for discrepancies identified during validations
oDevelop procedures for systems operations and sampling processes
DMCG
Arecibo, PR
Reliability Engineer
May 2015 – Aug 2016
oImplemented recommendations to assure tanks, vessels and piping in a Chemical Process Facility comply with API 510, 570 and 653 as well as ASME section 8
oDeveloped and implemented plan to assure chemical processes interlocks are tested
MERCK & CO
Arecibo, PR
Utilities Coach
Jan 2014– May 2015
oManage Site Utilities Operating Budget. Improved it from $7.2MM to $5.4MM.
oUtilities Systems SME. Assure water and compressed air systems are in compliance with company guidelines and regulatory agencies.
oPerform routinely interventions to system to test filters, perform chemical cleanings, replace gaskets and refurbish valves and pumps
oPerform investigation for test non-conformances and operations deviations. Implement CAPA as required
oComplete refurbish of a water distillation unit
oReplacement of a Water Softener unit
oConfiguration of automatic alarm level for conductivity monitoring
oModification USP water Cold loops operating sequence to be maintained within sanitization temperature while not in operation
oManage project for chilled water demand flow to control 17 AHU’S and Chilled water system equipment from BAS
oRecycling Water Project. Investment of approximately $40,000. Achieving reoccurring savings since January 2016 of $7,000 per month
oModifications to a 400HP boiler control system to operate in Low fire. Savings of 100 diesel gallons per day.
oImplemented a strong safety culture by assigning specific goals to team members in hazards identification and correction. No accidents in two years.
oLead site assessment and implementation of measures to be in compliance with NFPA 70E Arc Flash regulation and Machine Guarding.
Technical / Maintenance Expert
Aug 2005 – Dec 2013
oTechnical and Maintenance Support to Manufacturing Processes consisting of Granulation, Tablet Compression and Tablet Coating and Packaging. Systems Troubleshooting, Process defects and critical alarms investigations, CAPA and continuous improvements
oDeveloped maintenance technicians Capabilities Matrix to assure all the skills and knowledge necessary to provide manufacturing processes support.
oSupport to the introduction of 2 new solid dose products. Assure new facilities were aligned to site engineering procedures, design of maintenance strategy and technical support during qualifications and validations
oImplementation of peristaltic pumps to replace gear pumps in precision tablets coating process. Installation, control system tuning, Qualification, SOP
oCoached team for Tablets coater and gear pumps cleaning process modification. Risk and cleaning assessment, SOP and Cleaning forms revision
oUtilities and Maintenance lead in the construction of a new manufacturing suite. Approval of design and qualification protocols, FAT execution, verification of mechanical completions, PSSR and Start up.
oImplemented process for Management of Replacement Parts
oLed the Maintenance process stream in the SAP implementation. Design and SOP approval. Test execution.
oTechnical support during the automation of a blisters packaging line. FAT, SAT, IO/OQ, SOP and Modifications during start up
oDeveloped procedure to test high voltage magnetrons in a granulation/drying machine
oDesigned wiring, installed and qualified replacement for VFD obsolete models
oUpgraded speed control of a tablet press machine. From a mechanical system to VFD / PLC controlled. Installation, start up, qualification, SOP and training.
oLead a team to reduce under filled bottles and broken tablets customer complaints. Investigations, Root cause analysis, identification of actions, implementation and documentation of changes
Lean Six Sigma Project Manager
Nov 2004 – Aug 2005
oWorked with a team responsible Lean Manufacturing through the organization which enabled over $3MM in spending reduction over a 3 years period
oLed packaging line change over improvements. Identified opportunities, risk assessment, cleaning assessment, design of new process, implementation of changes and new SOP.
Maintenance Manager
June 2000 – Nov 2004
oResponsible to build and lead a team of Engineers and Technicians for the maintenance of Manufacturing, Packaging and Facilities.
oManaged Site Maintenance operating budget of 8.4MM
oImproved maintenance operations spending by $1.6MM in 4 years
oProvided technical support on process investigations related to equipment failures
oRedesigned Site High Voltage Distribution System maintenance
oImplemented PdM techniques for conditions based maintenance to eliminate 20% of PM workload and reduction in overtime by 50%
oAchieved savings over $500,000 in equipment parts replacement
oImplemented Mechanical Integrity Program to comply to PSM regulation
oSaved $150k in Maintenance cost by avoiding contracts to execute HEPA Filters Testing, Air Ducts inspections, Stainless Steel Passivation and Heat Exchangers Cleaning
oUpgraded Plant Fire Alarm System
Process Engineer
Jun 1998 – June 2000
oResponsible for the technical support of a Manufacturing process. Investigate deviations and implement CAPA
oImplemented actions to reduced 50% of quality deviations in Capsule Filling Process
oIncreased 20% in Capsule Fillings Machines output. This enable the elimination of one operating shift
oExecuted validation for capsules manufacturing process and coating suspensions holding time
oExecution of new Capsule Filling Machine Qualification
oExecuted Y2K verifications and implemented remediations for Part 11 compliance to process equipment PLC and computers.
Marion & Co
MANATI, PR
Project Engineer
Jun 1993 – June 1998
oManagement of Facilities Capital Projects
oIntegration of new BAS (Metasys) to control site AHU’S, Chillers and Fire Alarms
oInstallation of a new 20,000 cfm AHU with dehumidifier
oReplacement of obsolete dust collectors
oInstallation of a new 1500 ton chiller
oExpansion of site security system
oInstallation of infrastructure for new LAN
oAutomation of 6 vacuum pumps operation
oWAREHOUSE lighting retrofit
oUpgrade manufacturing areas AHU dehumidification control system
oDesign and installation isolated electrical emergency system for Laboratory and Communications room
oInstallation and commissioning of a new cooling tower electrical system
oQualification of automated control loops in an Hydrogenation process
AV ENGINEERING
MANATI, PR
Electrical Designer / Inspector
oDesign of Substation and Electrical System Distribution for the following projects:
PRASA sewer water pumping station – Orocovis 2003
Colegio Peritos Electricistas new facilities – Carolina 2003
New Christian Church – Aguadilla 2004
New air conditioning for Catholic Church – Isabela 2005
New private apartment complex – Cabo Rojo 2006
New Medical Surgery Clinic – Cabo Rojo 2007
Catholic church activity center – Sabana Hoyos 2008
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