BENJAMIN BERRIOS ROMERO; BSBM.

ALTURAS DE MONTE BRISAS

CALLE 16 No. 4-M-11

FAJARDO, PUERTO RICO 00738

787-***-**** / adsg24@r.postjobfree.com

Summary Of Qualifications: Significant experience in the development and execution of equipment qualification protocols: IQ/OQ/PQ, and Final Reports. Hands on experience in Manufacturing Process, Utilities, Packaging, Laboratory, Equipment Set Up, Production Supervisor and Instrumentation at the Pharmaceuticals, Biotechnology, Medical Devices and Electronic Industries. Heavy exposure to equipment set up, systems adjustment, maintenance and troubleshooting, Equipment Qualification and SOP generation. Effective management and reviewing of data, SOPs and LOTO Procedures, documentation and support validation and equipment qualification. Directly worked with cross-functional areas. Familiar with Labor laws. Working knowledge of pharmaceutical/biotech processes and Medical Devices industries. Familiarity with equipment qualification process, good documentation practices (GDP) and Risk Analysis in a highly regulated environment. Revision/URS Revision, Turnover package generation and data collection/Meeting, Factory Acceptance (FAT) and Site Acceptance testing (SAT) for Assembly, Testing and Process equipment.

Solid Dosage: Wet/Dry Granulation, High Shear Mixer, Niro Fluid Bed Dryer, Quadro Comil, Solution Mixer Tanks, Pack off, Blenders, Sievers, Post Hoist, Tanks. PLC and VFD troubleshooting and signals simulation; HMI and MAXIMO exposure.

Utilities: Exposure to qualification of the following equipment: Air Handling Units (AHU), USP Purified Water System, Compressed Air System, Re-heat Systems, Chilled Water System, Cooling Towers, and Vacuum Systems from protocols development, execution to Final reports submission.

Laboratory Equipment: Autoclaves, Incubators, Freezers, Ovens, and PH Meters; Familiar with Kaye Validator 2000 & Temperature Mapping. ApexZ3 Airborne Particle Counter.

Security Access Control and CCTV System: Executed Protocol and documented required testing (Interlocks,

Alarms Analog & Discrete, Power Loss Communication, Communication Loss, Environmental Condition testing, Software Version, Audit Trail Reports, etc.)

Other Skills: Traceability Matrix, URS, generation of SOPs and Work Instructions for calibration, maintenance and equipment operation. Equipment Qualification Protocol generation. Quality Systems; ISO 9000, FDA regulations, 134820; Windows: Word, Office, Excel, Outlook, OSHA, Technical Writer, and Electromechanical troubleshooting, Bilingual: English Spanish. Generation of Maintenance Plans and LOTO Procedures.

Education / Certification / Training: University of Phoenix- Bachelor of Science, Degree in Business Management (June 1998 to October 2000); University of Puerto Rico – Associate of Science, Degree in Electronic Engineering Technology (August 1979 to May 1981); Polytechnic University- Industrial Engineering (August 1983 to May 1985); University of Puerto Rico – Paralegal Certificate (March 2000)

EXPERIENCES:

Amgen AML, Juncos Puerto Rico (April 2022 to August 2022)

Sr. Validation Scientist:

Temperature Mapping

Equipment Periodic Reviews

Execution of Qualification (IOQ) of CRT (Controlled Room Temperature)

Installation and removal of Data Loggers

Generation of Summary Reports

(GVS) Fajardo, Puerto Rico (Under Integrated Services for Productivity and Validation Inc.)

(March 2022 to April 2022)

Qualification Specialist:

Generation, execution, and Final Summary Report for the qualification of two (2) Airborne Particle Counters Model ApexZ3.

BMS Humacao (OCT 2022 to Feb 2021)

Validation Specialist (CSV)

Generation of SAT (Site Acceptance Test) Protocol for Fette Tablet Press Model 3090i

Generation of IOQ (Installation Operational Qualification) Protocol for the Fette Tablet Press Model 3090i

Generation od User’s Requirements Specifications

Generation of TMX (Traceability Matrix) document for the Fette Tablet Press Model 3090i

Amgen LTD, Juncos, Puerto Rico (Jan 2021 to OCT. 2021)

C&Q Specialist

Supported the qualification execution of Ultra Low Temperature Freezers

Walk down and execution of Protocols to verify the installation of ferrules and instruments in a New 2

inches Process piping

Supported the initial inspection and receipt Verification (RVs) for instruments, hygienic and sanitary valves

and other equipment to be installed in for new lines addiction to existing Process.

Avara Pharmaceutical Services, Barceloneta, Puerto Rico (October 2020 to December 2020)

C & Q Specialist

Generation of IQ and OQ Protocols for Packaging equipment:

Enercon Induction Sealer, Retorquer, Omega Unscrambler

Users Requirement Specifications

Final Summary Reports

Romark Global Pharmaceutical, Manatí, Puerto Rico. (February 2019 to August 2019)

C & Q Specialist

General execution and documentation of Utilities Protocols: (USP Purified Water, Chlorination System,

Security Access Control and CCTV System)

Allergan Pharmaceuticals, Waco, Texas (Aug 2018 to Feb 2019)

Validation Specialist / SOP & Work Instruction Developer

Generation of Standard Operation Procedures (SOP), and execution to red lined before submission and

routing for approval for a Fryma Koruma Mixer.

Generation of SOPs and Work Instructions for IWK eyes solution filler packing machinery.

Generation of SOPs to operate Steris Parts Washer.

Dentsply Sirona, Inc. Las Piedras, Puerto Rico (March 2018 August 2018)

Validation Specialist

●Generation of Installation and Operational Qualification (IOQ) Protocols and Final Reports for Laboratory, Manufacturing and Packaging Equipment

●Generation of Standard Operating Procedures for Laboratory, Manufacturing and Packaging Equipment

●Generation of Calibration and Maintenance Procedures for Equipment

GSK Novalties, Humacao, Puerto Rico (November 2017 to February 2018)

Decommissioning Specialist

Generation, Execution and Final Reports for equipment and instruments to be decommissioned

after Hurricane Maria.

Haemonetics Inc. Fajardo Puerto Rico (December 2016 to September 2017)

Sr. Product and Process Engineer

●General revision of IOQ Protocols for Assets transition / Acceptant Test.

●Gap Assessment Evaluation.

●Technical Reviews.

●Development of Process Failure Mode Effect Analysis (FMEA)

Pall Life Sciences, Fajardo, Puerto Rico (January 2015 to October 2016)

Sr. Technical Consultant:

Generation, execution, and final reports of Commissioning/Qualification Protocols (IQ\OQ for

Utilities: Compressed Air System, Vacuum System, Reheat Water System, Bake Off Oven) and

Air Handling Units (AHU)

Generation of Standard Operation Procedures (SOP) for the operation and startup of Utilities

equipment.

Generation of Preventive Maintenance Procedures for equipment and systems as per

manufacturing specifications.

Generation of Log Out / Tag Out (LOTO) procedures for equipment and systems.

Lilly Del Caribe, Carolina Puerto Rico - (April 2015 to October 2015)

Commissioning and Qualification (C&Q) Specialist:

●General commissioning execution activities; execution of RV (Receipt Verification), IV (Installation

Verification).

●“Walk Down” with P&ID to identify major components and instruments were installed as per specifications.

●Execution of OC (Operational Commissioning) of flow valves, metering, agitators, pumps, piping, peristaltic pumps, tanks, solution tanks, pumps, and other Biotechnology process equipment.

Customed Inc. Fajardo, Puerto Rico – (October 2014 to December 2014)

Validation Specialist:

● Generation and execution of Installation and Operational Qualification Protocol (IOQ), and Performance Qualification (PQ) Protocol and Summary Report for the qualification of Tiromat 3000 Forming Seal and Kutter Machine and auxiliary equipment.

Lilly del Caribe, Carolina Puerto Rico - (Oct 2013- Feb 2014)

Qualification Specialist:

●Generation and review of Re-qualification Protocols for Laboratory equipment (Primus Autoclaves, Incubators, Refrigerators).

●General troubleshooting and temperature studies to Incubators running “Out of the specified temperature range”.

●Work coordination with external contractors for equipment calibration / service.

McNeil Healthcare, LLC, Las Piedras, PR (October 2012 – October 2013)

Member of the Work Plan Team (QS-9)

●Under Consent Decreed gathered identification, specification, and data verification of over 16,000 equipment and instruments from Compressed Air Systems, HVAC Systems, USP Water Systems, Analytical Micro-Lab and Manufacturing departments, to identify discrepancies between SAP PMs, P&ID drawings and other documentation.

●Walk down to perform “Field Verification” of the “As Built Conditions” and Red lined P&ID drawings as required.

●Entered captured data in client’s provided template and eventually entered the data in SAP System Share Point.

●Conducted equipment and system assessment to update data and reflect the “as built “conditions.

●Documents review, documentation auditing, recordkeeping, record compilation.

Supported Change Control Project (Compressed Air Filters Upgrading for Packaging area)

implementation and execution.

Merck Inc., Las Piedras, PR - (Jan 2012- Oct 2012)

Project Coordinator:

●Coordinated contractor's work and field activities.

●Supported the execution of the 190L Solution Tank and Mixer.

●Generated SOP's and Checklist for Process Equipment operation, cleaning, and maintenance.

●Generated SOPs for process room’s sanitation in new manufacturing area.

●Supervised and coordinated the installation of instrumentation and WIP SKID with contractors following specifications and P&ID's drawings.

●Supported the challenge and IOQ Protocol execution of equipment like Fluid Bed Dryer-Granulator, Pack Off, Post Hoist, Blenders, Quadro Comil, Sievers, instruments and valves using P&ID's, schematics and measuring equipment.

●Supported equipment troubleshooting of PLC, PID controllers and VFD by simulating input and output signals manually or with Signal Generators or using software system.

●HMI and MAXIMO exposure.

●Supported the execution of process validation and equipment following protocols, manufacturing procedures, recipes and SOP's.

●“Walk downs” to ensure that facilities, instruments and equipment were installed as per P&ID and design specifications.

●Supervised a crew of operators engaged in the new room’s sanitation process.

Amgen Manufacturing LTD, Juncos, PR – (March 2011- Oct 2011)

Vials Inspector:

● Conducted general inspection to vials, components, and syringes to ensure product complies with

specifications and regulated protocols.

Pall Life Sciences, Fajardo, PR – (Feb 2010- Jan 2011)

Equipment Set Up - Mechanic:

●Set up, calibration and troubleshooting to media corrugation machinery in order to properly fabricate industrial filters media.

●Assigned tasks to operators engaged in the assembly of industrial filters.

●Documented and investigated any out of tolerance event.

Boston Scientific, Miami, Florida - (Oct 2006- Jan 2007)

Validation Specialist:

● Generation and execution of Installation Qualification Protocols (IOQ’s) and summary reports for

a variety of equipment used in the assembly of medical devices.

Elli Lilly del Caribe Inc., Carolina, PR - (Oct 2004- Jun 2005)

Validation Technician:

●Inspected hygienic piping systems and subsystem according to isometric piping and instrumentation drawings (P&ID’s).

●Verified Isometric drawings to verify compliance with Good Documentation Practices as well as specifications.

●Supported the execution of Installation / Operational Qualification Protocols (IOQ’s) for equipment to be used in pharmaceutical process.

Wyeth Pharmaceuticals, Carolina, PR – (March 2004- July 2004)

Equipment Setup Technician:

● Set up, calibration and mechanical adjustment to product filling lines and equipment in Aseptic areas.

Paralegal Services & Associates, Bayamón, PR (Sept 1990- June 2004)

Legal Assistant:

●General assistant to Lawyers in trial preparation, investigations, depositions, client interviews, case follow up.

●Preparation of motions and interrogatories.

●Interview and evaluation of Clients’.

Squibb Pharmaceuticals, Humacao, PR - (Aug 1989- June 1990)

Manufacturing Operator:

●Operated a variety of equipment used to manufacture pharmaceutical products.

●Equipment operated included reactors, centrifuges, filters, scales, valves, controlling instruments, distillation equipment, Manesty compression machines, forklift trucks, pallet jacks.

●Completed all the equipment and operation (Batch record) required documentation.

Schering Plough – Las Piedras, PR – (Feb 1988- Aug 1989)

Instrumentation Technician / Mechanic

●Preventive maintenance, set up of Packing lines, instrument calibration, troubleshooting to process and packing machinery.

●Worked directly with the installation and maintenance of the Partena Blister Packaging Machine.

●Equipment modification to Manesty Tablets Compression Machinery.

●Preventive Maintenance (PM) and calibration of metal detectors and scales.

●Documented calibration and PM’s.

Intel Caribe, Inc., Las Piedras, PR. (April 1981- Nov 1987)

Electronic Technician:

●Diagnostic and troubleshooting of printed circuit boards to the component level.

●Repair of printed circuit boards and microcomputers using basic soldering skills, multi-meters, schematics, signal simulators and oscilloscopes.

●Familiar with surface mount, wave soldering / disordering techniques.

Intel Caribe, Inc., Las Piedras, PR Production Supervisor: (Promotion):

●Overseed all productions activities and personnel to ensure compliance with production schedules and Quality specifications and requirements.

●Ensured that standard production processes were maintained, and that production volumes and quality were met.

●Employee’s performance appraisers.

●Personnel safety and compliance with local and federal labor laws.

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