Engineer Quality Control
Resume:
Bruno Franco Romero
**********@*****.***
http://pr.linkedin.com/pub/bruno-franco/31/928/67
PROFESSIONAL PROFILE
A senior engineer with more than 20 years of successful and progressive experience in operations,
engineering, quality and project management, with a solid track record, special ability to identify and modify
areas in need of improvements.
Comprehensive professional services experience as a consulting engineer at Pfizer Pharmaceuticals LLC in
Caguas, Puerto Rico. I’ve been with Pfizer for the last five years. My accomplishment was administer and
improved effectively the operation of engineering calibration laboratory, also worked with some the
optimization project in engineering operations.
Able to work efficiently and carefully, hard worker and organized, responsible and honest friendly and
cheerful, disposition, hospitality and excellent service spirit.
PROFESSIONAL EXPERIENCE
Consultant Engineer
2011 2012 Pfizer Pharmaceutical LLC Barceloneta Puerto Rico
2006 2010 Pfizer Pharmaceutical LLC Caguas Puerto Rico
Developed of the master instrument list for a new innovative state of the art manufacturing process
(Continuous Dry Granulation). Applied the appropriate instrument critically classification for new instruments,
and prepared the appropriate documentation to add the new instrument s to CMMS. Coordinated the first
calibration with the external contractors.
Reviewed the master instrument database (3800 objects) as part of optimization initiatives in engineering
operations. The scope work of the project included: standardized the object description, input/output ranges,
manufacturer accuracy specification, calibration tolerance, calibration freque ncy, critically, applicable SOP’s,
applicable “type/category” of the objects. A calibration optimization guideline was written as part of the
optimization project. An engineering changes request was approved to implement the optimization project.
Implemented “loop calibration” whenever possible. The assessment is part of optimization initiatives in
engineering operations. Environmental monitoring panel (EMP) consists of three digital indicators and two
transmitters (difference pressure transmitter and RH% transmitter). The current calibration approaches
required of five (5) calibration work orders to certificate each EMP’s panel; each object was calibrated
individually. A total of 130 panels (EMP’s) were identified in the manufacturing areas. The new calibration
approaches required only (1) calibration work order to certificate each panel. The new calibration work order
contains the all information required to certificate temperature, relative humidity and differential pressure
(measurement ranges, calibration tolerance per measurement units, EMP’s identification number). The annual
certification required 1300 work orders; with loop calibration approach required only 260 work orders. The
optimization initiative was fully implemented.
Calibration Supervisor • Electrical & Calibration Engineer
2004 2006 Pfizer Pharmaceutical LLC Caguas Puerto Rico
2000 2004 Cardinal Health Puerto Rico Humacao Puerto Rico
1998 2000 Alcon Puerto Rico, Inc. Humacao Puerto Rico
P.O. BOX 2500 PMB-21 Trujillo Alto, P.R. 00977-2500 Mobile: 787-***-****
Bruno Franco Romero
**********@*****.***
http://pr.linkedin.com/pub/bruno-franco/31/928/67
1994 1997 Bristol Myers Squibb Company Barceloneta Puerto Rico
1989 1994 Syntex Puerto Rico, Inc. Humacao Puerto Rico
Managerial and administrative responsibilities to ensure compliance in the calibration program execution.
Extensive experience in Calibration Laboratories. Specialized in administrating the engineering cal ibration
center and quality control laboratories (analytical instruments and analytical systems) in the pharmaceutical
industry. Ensure compliance with the internal quality system and the federal agencies.
Successful support to engineering department, technical service and manufacturing in the installation of new
instruments and equipments. Conducted start-up and qualifications.
Strong familiarized with many calibration & maintenance programs such as Calibration Manager (Calman),
Maximo Calibration Program (ver. 7) and Datastream Asset Management.
Directly responsible of the preparation of the contract service agreements for analytical equipments installed in
the chemistry and microbiology laboratories.
Extensive experience in process control improvements. Developed and implemented single loop control for
many systems (fluid bed dryers, steam sterilizers, ovens and enhanced others systems). Experience in cost
estimating, sizing, selection, specification and purchasing, installation and start-up. Experience in
troubleshooting and loop tuning. Experience in developing and reviewing P&ID for new process.
Provided technical assistance for proper interpretations, guidance, and training to industrial regar ding Quality
Management Systems (ISO 900 series), ISO/IEC 17025 Quality Manual, NIST Handbook 44, NVLAP
National Voluntary Laboratory accreditation Program, A2AL American Association Laboratory Accreditation.
Conducted internal technical audits of the calibration laboratory to ensure traceability of the standards and
compliance with the international standards ISO/IEC 17025 and guidelines.
Evaluated the test accuracy radio (TAR) for mass, temperature, pressure and electronic test equipments used
as calibration standards.
Experience to evaluate and determinate the uncertainty contributions in many measurements (TUR).
Experience to define and determine equipment specifications (accuracy, linearity, hysteresis and repeatability)
to customs mechanical and electronic equipments.
Performed reverse traceability to identify instruments o equipments that has been calibrated with the out of
tolerance standard. Evaluate the magnitude of the OOT condition to determine, if the product quality or the
process quality had been impacted directly or indirectly by the out -tolerance-condition. Prepare the OOT
report and corrective actions.
Directly responsible for maintenance, calibration, and upgrading of steam sterilizer units such as Fedegary,
Finn-Agua and Amsco. Developed maintenance and calibration procedures. Extensive experience in
troubleshooting and corrective actions. Planned and coordinated the shutdown schedules activities for steam
sterilizers. Interface with mechanical contractors, technical specialized services, consulting and testing.
Experience to determine and report uncertainties for balances and scales (class I, class II and class III) .
Developed calibration and test procedures. Experience in sizing, procurement, installation and qualification.
P.O. BOX 2500 PMB-21 Trujillo Alto, P.R. 00977-2500 Mobile: 787-***-****
Bruno Franco Romero
**********@*****.***
http://pr.linkedin.com/pub/bruno-franco/31/928/67
Developed and implemented a calibration center for a pharmaceutical industry. Developed the calibration
program procedure, calibration test procedures (SOP’s) and calibration management description. Calibration
Management (CALMAN) was selected to manage the calibration schedule in the site. Experience to
administer and manage CMMS for calibration area.
Developed and implemented a filter integrity test room for a pharmaceutical industry. Developed the filter
integrity program, the filter integrity test procedure and the calibration procedure for integrity test equipments.
The filter integrity test room provided filter certification to membrane filters for vents applications and
compressed air point of use. Familiarized with Millipore and Pall integrity test units.
Consulted with the external calibration service representative on testing techniques and methodology to define
the number of test measurements, types of comparisons necessary and the applicable test accuracy
specification for critical instrumentations.
Experience to evaluate the uncertainty contributions in many process measurements and systems to define
the systems specifications (accuracy, linearity, hysteresis and repeatability).
Production Manager • Production Supervisor
1988 1989 Baxter Healthcare Corp. Carolina Puerto Rico
Managerial and administrative responsibilities that included: Prepare and coordinate production schedule for
three shifts and weekend shift in the manufacture of vinyl mini bags to be filled with intravenous solution
(total manufacturing operations of 68 persons). Supervised administrative production supervisors and
maintenance Engineer.
Supervised and coordinated activities of second shift operations, in accordance with personnel and equipment
resources (second shift manufacturing operations of 21 persons). Strong familiarized with all basic policies in
pharmaceutical manufacturing environment.
Plant Maintenance • Production Maintenance Engineer
1994 1997 Bristol Myers Squibb Company Caguas Puerto Rico
1989 1994 Syntex Puerto Rico, Inc. Humana Puerto Rico
1987 1988 Baxter Healthcare Corp. Carolina Puerto Rico
Responsible for repairing and maintaining all mechanical systems in the RF welding process and mechanical
parts that includes hydraulic systems, pneumatic systems, pump overhauls, and gene ral machine repairs.
Planned and coordinated the shutdown schedules activities and done critical tasks. Interface with contract
manufactures, services, consulting and testing.
Prepared preventive maintenance schedules. Implemented the predictive maintenance program for motors
pumps, transmissions and fans.
Directly responsible for the optimum equipment operations and maintenance program of a chemical plant
(Fully automatic operations, process automation integrated with ABB Taylor - DCS).
Familiarized with class 1, division 1 & 2 instrumentations. Reinforced high quality and precise maintenance
and accurate calibration execution.
P.O. BOX 2500 PMB-21 Trujillo Alto, P.R. 00977-2500 Mobile: 787-***-****
Bruno Franco Romero
**********@*****.***
http://pr.linkedin.com/pub/bruno-franco/31/928/67
Strong familiarized with plant preventive maintenance and predictive programs. Provide services to utilities,
building & ground. Extensive experience with following equipments and process; reactors, centrifuges,
vacuum system, compressed air, breathing air, heating exchangers and others.
USP water systems, HVAC units and cooling towers, heating exchangers and others.
Developed and implemented cost of maintenance reduction programs.
Quality Control Supervisor • Quality Control Engineer • Test & Reliability Engineer
1986 1987 Intel Puerto Rico, Inc. Las Piedras Puerto Rico
1981 1986 ITT Qume Caribe, Inc. Humacao Puerto Rico
1979 1981 DTS Caribe, Inc. Vega Baja Puerto Rico
Responsible for maintain the test equipment updated with the changes and implementing the eng ineering
change orders (ECO) to print circuit boards in manufacturing area.
Developed and implemented test methods to evaluate with precision and accuracy of PCB asse mblies at
various stages of manufacturing process.
Conducted extensive reliability testing and made failure analysis to identify assignable failure mode to
electromechanical devices, circuit boards and components.
Established and standardized data collection systems in manufacturing process. Implemented the process
control charts in manufacturing areas to monitor the stability of processes.
Prepare quality control reports and the reliability reports in weekly basis. Summit the appropriate corrective
actions to improve product quality and reliability at substantially lower cost.
Developed and implemented test methods to evaluate with precision and accuracy electronics components in
incoming inspection area.
Developed and implemented a test laboratory for an electronic company. Developed the calibration program
procedures in compliance with the U.S. military calibration standard (MIL-STD 45662). Developed the
calibration test procedures. The test laboratory provided services of calibration, reparations, upgrading,
conduct failure analysis and reliability studies.
Experience in calibration test procedure for oscilloscopes, AC/DC multi-meters, AC/DC power
supplies, resistor boxes, temperature indicators, rpm indicators, timers and counters.
P.O. BOX 2500 PMB-21 Trujillo Alto, P.R. 00977-2500 Mobile: 787-***-****
Bruno Franco Romero
**********@*****.***
http://pr.linkedin.com/pub/bruno-franco/31/928/67
EXPERIENCE IN THE FOLLOWING SYSTEMS
Calibration Program Execution / Preventive Maintenance Execution & Analytical Laboratory Balances & Floor
Optimization & Implementation Optimization scales installations & testing
Process & Mechanical Engineering Failure Analysis & Reliability studies Autoclave units, 0vens, SIP & VHP.
Water process, Pre-treatment, RO units,
Electrical & Instrumentation Engineering TOC analyzers installation & operation
Still,Clean Steam Gen.
Procurement Support &
Develop and Review Contract Service
Project Management Filter Integrity Test Calibration
Agreement
DCS experience (ABB Taylor) operations
Electrical & Instrumentation Engineering/
KAYE Calibration & maintenance
P&ID development
Factory Acceptance test (FAT) and Development of Test Instructions & Dryer systems, Vacuum systems, Heating
commissioning Installation Qualifications (IQ) Packages, Chillers & Cooling Towers
MAXIMO (ver. 7) Calibration & Preventive DATASTREAM Calibration & Maintenance Calibration Manager (CALMAN)
Maintenance Program Operations Program Operations Operations
FETTE Table Presses 3090i Maintenance
Advance RF Welding Technology Glatt Fluid Bed Maintenance & Calibration
Experience
Experience
EDUCATION
Bachelor Degree in Electrical Engineering 1979
Recinto Universitario de Mayaguez, Mayaguez, Puerto Rico
High School Degree 1970
Colegio La Salle, Barranquilla, Colombia
P.O. BOX 2500 PMB-21 Trujillo Alto, P.R. 00977-2500 Mobile: 787-***-****
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