Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) Email & Phone Number

Chapel Hill, Nc, Us

Dallas, Tx, Us

At Jacobs, we're challenging today to reinvent tomorrow by solving the world's most critical problems for thriving cities, resilient environments, mission-critical outcomes, operational advancement, scientific discover and cutting-edge manufacturing, turning abstract ideas into realities that transform the world for good.Site: FUJIFILM Diosynth Biotechnologies- Review and execute Start-Up and Commissioning documents according to GDPs.- Start-Up equipment in a Safe and Effective manner.- Provide Technical Assistance and input.- Coordination with Construction Management Firm as needed.

Raleigh, North Carolina, Us

New York, New York, Us

Pfizer is a research based Biopharmaceutical industry engaged on the discover, development, manufacture, and distribution of Healthcare products.- Authored and executed Development and Exhibit Batches Protocols, and Process Simulation Media Fill (PSMF) protocols.- Executed trials batches, scale-up batches, and exhibit batch protocols to support process development.- Development of Verification / Qualification deliverables including but not limited to Requirements Documents (RDs), Functional and Design Specifications (FDS), Test Protocol (IQ / OQ / PQ) and Summary Reports.

Wilmington, Nc, Us

Raleigh, North Carolina, Us

Setup, Calibrated, Validated and Tested a Supercritical CO2 Dyeing Lab Scale Machine. Mentor and training graduate students at the College of Textiles, NCSU.

Blue Bell, Pa, Us

Blue Bell, Pa, Us

Pfizer is a research based Biopharmaceutical industry engaged on the discover, development, manufacture, and distribution of Healthcare products. This work was performed in the R3 site at Pfizer, RM, USA.- Responsible for preparing, assembling, executing forty-six (46) IQ/OQ protocols for the R3 Pfizer project and starting the execution of OQ (Formulation) protocols.- Supported the R3 project team for the completion of the Commissioning, Engineering Studies and Qualification for four (4) of the five (5) major filling lines.- Performed cGMP Compliance based services (Commissioning, Qualification, Validation, Consulting, etc.) as developed and defined in projects agreements with IPS' clients.

Lab-scale system was setup to execute experimental CO2 Dyeing trials at NCSU.

Long Beach, Ca, Us

- Reviewed and drafting Lab Batch Records (LBRs) template and Standard Operating Procedures for use of LBRs and creating them for existing Methods from drafted template.- Supported the qualification and remediation of Lab Instruments (HPLC, UPLC, Mass Spectrometer) used for Chemical Testing in the Biopharm industries. My role as a Validation Engineer, I was responsible for creation and execution of validation periodic reviews for Lab Instrumnets and final reports.

Long Beach, Ca, Us

Supported the qualification and remediation of Lyophilizers, Filler and Autoclave cycles for BCG Facility. As an Equipment Validation Engineer, I was responsible for creation and execution of validation and qualification protocols (IQ, OQ, PQ) and final reports.

Copenhagen, Dk

- Prepared protocols, including cycle development protocols, investigational/engineering study protocols (IQ, OQ & PQ), amendments and supplements for critical systems as directed by validation manager.- Reviewed protocols drafts and resolves circumstances in order to achieve management pre-approval.- Researched equipment/processes, and establishes parameters and methods to test equipment to meet validation requirements.- Coordinated the execution of qualifications and all aspects of the validation project with other departments, including but not limited to operations, quality control, and quality assurance for completion of validation requirements.- Reviewed, analyzed and compiled protocol data in preparation of interim and final reports for management review and approval.- Executed re-qualification studies and periodic reviews, to assure equipment maintain within its qualified condition. Also, maintains equipment used for qualification purposes. - Executed cleaning validation protocols and perform others duties as assigned by Validation Manager.- Ensured that all production equipment (utilities) are configured in a 21 CFR Part 11 Compliance (Electronic Records Assessment Work Sheet) / Annex 11 Complaint manner.

- Consulted on technical and strategic issues on scale-up and commercialization of novel greentechnologies for different applications.- Expertised in product/process development engineering and equipment Validation (compliance, qualification and commissioning) and R&D/Analyical Chemistry/GLP/GMP laboratory quality practices for pharmaceuticals products.- Expertised in Supercritical Fluid Technology in Textiles (Oversea Contract), Extraction and Pharmaceuticals Applications.- Expertised in Water Purification System.

Lake Forest, Il, Us

- Reviewed, executed, and summarized validation protocols (IQ, OQ, PQ, PV and/or CV) for aseptic pharmaceutical manufacturing processes.- Executed protocols including cycle development (Moist Heat Sterilizers) to deliver fully functional recipes for use in manufacturing operations.- Commissioned and qualified utilities associated with the Sterilizers such as oil free compressed air and purified water systems. - Tested critical and key process parameters (sterilizers) to assure reliability, quality and proper documentation to support the associated process and results.- Worked with project engineers and other support groups to have an in-depth-understanding of new and existing equipment capabilities.- Executed validation protocols (EDC) for sterilizers

Buffalo, New York, Us

- Provided validation services (using Kaye Validator and Kaye data loggers) for laboratory equipment such as Centrifuges, Horiba CBC, Gene Pulser Xcell Electroporator, Freezers, Refrigerators and Incubators. - Calibrated thermocouples (pre/post calibration) for temperature mapping studies: Kaye Validator and software Validator to perform calculation, analysis and interpretation of data for equipment qualification studies. - Provided support of controlled temperature environments, including design, regulatory requirements, and techniques used to test and validate, mainly incubators, refrigerators, and freezers.- Assisted qualification protocols and execute qualification activities for lab equipment projects for clients in support of cGMP/FDA requirements.

- Assembled, designed and tested a full scale laboratory Clean Water Unit (CWU) for water purification. Provided technical support to resolve processing issues in existing process in order to maximize efficiency and productivity of the water purification process.- Generated of engineering specifications and drawing, review of engineering documents, field-testing of equipment/systems such as air compressors, ozone generators, reverse osmosis vessels and PLC/HMI control system). - Assisted with the identification, development, installation, and start up of process improvements. Engineering assignments may include energy and material balance studies, process studies, and process equipment specifications and modifications- Assisted and collaborated on writing and executing of manufacturing testing protocols (FAT and SAT), creating commissioning plans, reviewing submittals for commissioned water systems and final reports summarizing testing activities and deviations across a wide variety of equipment.- Visited sites to verify water system installation, quality and readiness for testing, documentation inconsistencies or deficiencies in system, operation and compliance.- Performed troubleshooting and minor code changes to Siemens PLCs and HMIs.The combined work helps strengthen SunStone's position in the water purification market.

- Field execution of commissioning, qualification, and validation of equipment, utilities, cleaning processes, computer systems, temperature mapping, laboratory equipment (such as freezers, centrifuges, water baths, Guava Flow Cytometry, and cell viability analyzers) and controlled environments. - Ensured that functional specifications, qualification protocols, and summary reports are consistent with Good Documentation Practices prior to an after execution. Created and executed OC and IOQ for CTUs (Lab and Large Sizes).- Executed installation and operational protocols (IOQs) for portable particle monitoring systems (Lasair models 310 C and 350 L) ans SMA MicroPortable Viable Air Samples.

Raleigh, North Carolina, Us

The Norwegian Trust Fund for Private Sector and Infrastructure (NTFPSI). Terms of Reference (ToR): Diagnostic for the Use of Tropical Banana Plants for Textiles in Honduras. Banana fibers obtained from the stem of banana plant have shown significant applications in the textile arena. Natural fibers have great advantages such as low density, appropriate stiffness and good mechanical properties and high disposability and renewability. A major application of the banana fibers have been in reinforcement materials.Multi-tasking Engineer working with green development design on processing that includes Hi-Tech Technologies. Write research proposals and partnership with small companies.

Raleigh, North Carolina, Us

Mentored undergraduate and graduate students. Worked with colleagues in R&D projects and helped to write grant proposals to bring financial suppport to the University.

Raleigh, North Carolina, Us

Worked on the development of analytical methods/techniques for the determination of a simulant chemical agent vapor used in the pilot scale Man-In-Simulant-Test (MIST) chamber. Phase I of the research deals with the operation, optimization and validation of the MIST chamber. Finally, I built up chemical laboratory activities (handling hazardous waste disposal) level to support all the chemicals tests at TPACC.In addition at TPACC, I worked with an important research project on developing a chemically protective Boot system with leather upper. I worked closely with other TPACC staff and graduate students to characterize the resistance of leather candidates to penetration and splash of target toxins and on decontamination of the leather materials after exposure to toxic industrial chemicals (TICs). This research project was very sucessful and the resulting new protective Boot is currently in a one year field test.

Raleigh, North Carolina, Us

I worked as a Chemical Research/Process Professional at the Textile Protection & Comfort Center (TPACC) in NCSU. I performed analytical chemical tests (penetration, splash, permeation and liquefied permeation tests) on protective garments. Also, I worked on the Man-In-Simulant Test (MIST) new chamber in TPACC. The MIST is an evaluation of the chemical vapor protective performance of a complete proctective ensemble. MIST provides an overall evaluation of all aspects of particular protective ensemble, including the garment, gloves, footwear, respirators, and interface devices. Finally, I was involved to conduct whole simulant exposure (MIST) tests, and analyzed simulant absorbed on PADs with GC/FID, GC/MS and HPLC.

Raleigh, North Carolina, Us

I worked on the characterization and evaluation of the electrospinning process as an alternative tecnique in which polymer fibers (such as PEO, PCL and Lignin) are formed (submicron-scale diameters) by accelerating a fluid jet stream to a high electric field. Instruments include: SEM, TEM, DMA, DSC and TGA.

I worked on the characterization and evaluation of supercritical fluid technology (SFT) as an environmentally friendly extraction technique in the Nutraceutical field. I assisted with the supercritical extraction process, product development and marketing support of the alternative SFT for the extraction of Active Pharmaceutical Ingredients (API). Also, I executed validation protocols for lab equipment (centrifuges, freezers, etc.) and process equipment validation. Finally, I collaborated with the design of a novel high-pressure countercurrent column system that can be used to perform research and development of advanced supercritical fluid processes for lemon (and other botanical sourced liquids and slurries) in Tucuman, Argentina

Nashville, Tennessee, Us

Developed, tested and scale-up Supercritical Fluid Technology for Soil Remediation

Research Assistant Professor, Product/Process Development Engineer

B.Sc., Chemical Engineering

M.Sc., Polymer Science

Process Development Engineering (Supercritical Fluid Technology)