Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) Email and Phone Number
Chapel Hill, NC, US
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s Location
Raleigh-Durham-Chapel Hill Area, United States, United States
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s Contact Details
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) work email
- Valid
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) personal email
n/a
About Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)
Sr. Validation Engineer at the Pharmaceutical Industry, NC. I can bring 10+ years experience and skills in validation methodologies to complete tasks, prepare protocols including, cycle development, perform installation (IQ) and operational protocols (OQ) duties and review daily operating metrics.Experienced with Aseptic techniques while performing validation laboratory equipment and large scale moist heat sterilizers. Worked in a cGMP environment and have excellent engineering skills and process development. Creative problem solver, able to process and resolve issues using Six Sigma principles.Hands-on mechanical and chemical engineering skills. A self-motivated and creative person with the ability to work in a multi-disciplinary team environment. Fluent in English and Spanish and willing to relocate.Specialties:Validation TechniquesValidation/CommissionEquipment Validation: Refrigerators, Incubators, Freezers, Centrifuges, Portable Particle Monitoring Temperature MappingValidation SoftwareCleaning ValidationFedegari SterilizersFAT/SAT/IQ/OQ/PQ ProtocolsTurn Over Packages (TOPs)Personal Protective Equipment (PPE)Chemical Testing Methods (NFPA/ASTM)Nanotechnology (Hands-on thermal analysis and analytical instruments include: SEM, TEM, DMA, DSC, TGA, GC-FID/MS, and TD)Supercritical Fluid Technology (SCFT) - High Pressure EquipmentMedical Textiles Applications and Chemical Product/Process DevelopmentDesign of Experiments (DOE)
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s Current Company Details
Pfizer
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Sr. Validation Consultant (Transfer Service) and Engineer
Chapel Hill, NC, US
- Website:
- pfizer.com
- Employees:
- 100690
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) Work Experience Details
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Sr. Validation Consultant (Transfer Service) And EngineerPfizerChapel Hill, Nc, Us
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Hvac Start-Up Engineer: Black Utilities (Life Sciences)Jacobs Sep 2024 - PresentDallas, Tx, UsAt 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. -
Adjunct Assistant ProfessorNorth Carolina State University Jun 2024 - PresentRaleigh, North Carolina, Us -
Sr. Validation Consultant (Tech Transfer Support) / EngineerPfizer Jun 2023 - Jul 2024New York, New York, UsPfizer 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.
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Sr. Validation EngineerAlcami Corporation Mar 2021 - May 2023Wilmington, Nc, Us -
Sr. Consultant EngineerNorth Carolina State University Mar 2020 - May 2023Raleigh, North Carolina, UsSetup, Calibrated, Validated and Tested a Supercritical CO2 Dyeing Lab Scale Machine. Mentor and training graduate students at the College of Textiles, NCSU.
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Sr. Engineer, CqvIps-Integrated Project Services, Llc Feb 2020 - Mar 2021Blue Bell, Pa, Us -
Senior Engineer, CqvIps-Integrated Project Services, Llc Feb 2020 - Jan 2021Blue Bell, Pa, UsPfizer 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.
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Senior Engineer ConsultantGreen Consultant Apr 2019 - Dec 2020Lab-scale system was setup to execute experimental CO2 Dyeing trials at NCSU.
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Sr. Validation EngineerMangan Inc. Oct 2019 - Feb 2020Long 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. -
Validation Engineer IiMangan Inc. Jun 2019 - Sep 2019Long Beach, Ca, UsSupported 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.
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Validation Scientist (Engineer)Xellia Pharmaceuticals Jul 2015 - May 2019Copenhagen, 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. -
Consultant Engineer/OwnerGreen Consultant Engineers Sep 2012 - Jan 2016- 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.
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Validation Engineer I (Contract) - Compliance Technology GroupHospira Jul 2014 - Jul 2015Lake 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 -
Equipment Validation Consultant At Argos Therapeutics, Inc. (Contract)Compliance Team, Inc. Mar 2013 - Jun 2014Buffalo, 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. -
Process Engineer/Commissioning/Equipment ValidationSunstone Water Group Dec 2012 - Dec 2013- 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.
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Validation Engineer (Contract) - Valsource (Varicella Bulk Expansion (Vbe)) FacilityMerck Jun 2012 - Sep 2012- 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.
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Adjunct Assistant ProfessorNc State University Jan 2010 - Dec 2011Raleigh, North Carolina, UsThe 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.
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Adjunct Assistant ProfessorNc State University Jan 2009 - Dec 2011Raleigh, North Carolina, UsMentored undergraduate and graduate students. Worked with colleagues in R&D projects and helped to write grant proposals to bring financial suppport to the University.
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Chemical Research Assistant/Validation EngineerNc State University Mar 2009 - Mar 2011Raleigh, North Carolina, UsWorked 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.
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Chemical Research ProfessionalNc State University 2008 - 2009Raleigh, North Carolina, UsI 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.
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Research Associate FellowNc State University 2005 - 2008Raleigh, North Carolina, UsI 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.
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Equipment And Process Validation/Process Improvement EngineerHerbalscience, Llc Sep 2004 - Oct 2005I 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
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Research AssociateVanderbilt University May 1993 - May 1996Nashville, Tennessee, UsDeveloped, tested and scale-up Supercritical Fluid Technology for Soil Remediation -
Research EngineerIntevep, S.A. 1985 - 1990
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) Skills
R&d
Process Engineering
Validation
Hplc
Product Development
Process Improvement
Laboratory
Gmp
Nanoparticles
Differential Scanning Calorimetry
Process Optimization
Quality Assurance
Manufacturing
Laboratory Research
Gc Ms
Nanocomposites
Characterization
Tem
Fda Gmp
Dsc
Nanofibers
Kaye Validator
Operational Qualification
Protocol Analysis
Commissioning
Equipment Installation
Gc Fid
Ic
Sem
Aspen Plus
Matlab
Nanofabrication
Large Scale Systems
Aseptic Technique
Aseptic Processing
Sop Development
Plc 5
Computer System Validation
Laboratory Analysis
Sfc
Thermal Desorption
Ase
Laboratory Experience
Laboratory Techniques
Supercritical Fluid Technology
S7 300
Risk Analysis
Data Validation
Instrument Validation
Validation Change Management
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) Education Details
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North Carolina State UniversityProduct/Process Development Engineer -
Universidad Del ZuliaChemical Engineering
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Vanderbilt UniversityPolymer Science
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Vanderbilt UniversityProcess Development Engineering (Supercritical Fluid Technology)
Frequently Asked Questions about Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)
What company does Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) work for?
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) works for Pfizer
What is Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s role at the current company?
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s current role is Sr. Validation Consultant (Transfer Service) and Engineer.
What is Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s email address?
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s email address is mo****@****uno.com
What schools did Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) attend?
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) attended North Carolina State University, Universidad Del Zulia, Vanderbilt University, Vanderbilt University.
What are some of Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s interests?
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) has interest in Social Services, Children, Politics, Education, Environment, Science And Technology, Health.
What skills is Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) known for?
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls) has skills like R&d, Process Engineering, Validation, Hplc, Product Development, Process Improvement, Laboratory, Gmp, Nanoparticles, Differential Scanning Calorimetry, Process Optimization, Quality Assurance.
Who are Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s colleagues?
Gerardo A. Montero, Hvac Start-Up Eng. Black Utilities (Ls)'s colleagues are Michelle Woo, Sounak Chatterjee, Samira Toghanian, Balamurugan Sengottuvel, Alexandra M Peeva (Work), Malleswararao Nandigam, Thuy Bui.
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