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Jeffery Gloyer, M.Eng, brings over 6 years of specialized experience in pharmaceutical facility design and compliance to his role as Chief Operating Officer and Co-Founder of Vigor. Holding a Master of Engineering (Systems Engineering) from Arizona State University, Gloyer's career began at an FDA registered third-party testing laboratory, where he specialized in engineering, facilities design, qualification, and validation under current Good Manufacturing Practice (cGMP) rules.Jeff’s expertise in pharmacy design is extensive, having designed over 100 pharmacies, including sterile and non-sterile compounding areas and negative pressure zones for hazardous drug compounding. His designs consistently ensure compliance with USP chapters <797>, <795>, and <800>. His experience extends to larger-scale projects, including the successful start-up and commissioning of multiple pharmacies, analytical laboratories, and FDA registered 503B outsourcing facilities.In the realm of regulatory compliance and quality systems, Jeff has developed and evaluated systems for both 503A pharmacies and facilities following Good Manufacturing Practice (cGMP). He has conducted gap analysis and due diligence facility audits, ensuring adherence to USP, FDA, and other regulatory standards. His expertise also encompasses cleanroom certification, pharmaceutical equipment calibration and validation, and sterile compounding equipment selection.At Vigor, Jeff applies his comprehensive knowledge of facility design and cGMP compliance to oversee the operational aspects of the company. His background in managing multi-million dollar design and build projects, including a $50 million project for a 503B facility and a $25 million project for an analytical laboratory, positions him uniquely to drive operational excellence and regulatory compliance in the pharmaceutical compounding industry.
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Chief Operating OfficerVigor Jan 2024 - Present -
Engineering ConsultantEagle Sep 2024 - PresentHouston, Texas, Us -
Principal EngineerEagle Apr 2018 - Apr 2024Houston, Texas, UsAn integral part of facility start-up to include commissioning and qualification. The lead engineer on multiple multi-million dollar laboratory and pharmacy construction projects . The facilities included ISO 8 and ISO 7 classified clean rooms, as well as HD and Non-HD non-sterile manufacturing areas. These facilities were constructed and operate as cGMP facilities.Lead consultant on facilities design for the placement of a clean room environment in compounding pharmacies. This includes the placement of sterile, non-sterile, and hazardous drug areas. Proficient in the content of USPs <795>, <797>, and <800> particularly in regards to facilities design. Also proficient in 21 CFR Parts 210, 211, and 212. Actively manage multiple projects at any given time.Created and developed the Engineering department at Eagle Analytical. This department focuses on Validation services for equipment used in Pharmacies and cGMP operations. Experience writing and executing URS, FS, DQ, IQ, OQ, and PQ in a cGMP setting. Experience with using Kaye Validator AVS system. Extensive knowledge of quality systems in a GMP setting. Created a Metrology function within the Engineering department which focuses on calibration services. The program was initially developed to serve internal operations for laboratory equipment. The system is actively being developed to provide external services as well.Created a Cleanroom Certification function within the Engineering department which focuses on certification of cleanroom and associated primary engineering controls to CETA standards. The program was initially developed to serve internal operations, but has been expanded to provide external services as well.
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Jeff Gloyer Education Details
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Ira A. Fulton Schools Of Engineering At Arizona State UniversitySystems Engineering -
Ira A. Fulton Schools Of Engineering At Arizona State UniversityEngineering (Electrical Systems)
Frequently Asked Questions about Jeff Gloyer
What company does Jeff Gloyer work for?
Jeff Gloyer works for Vigor
What is Jeff Gloyer's role at the current company?
Jeff Gloyer's current role is Chief Operating Officer at Vigor.
What is Jeff Gloyer's email address?
Jeff Gloyer's email address is je****@****her.com
What is Jeff Gloyer's direct phone number?
Jeff Gloyer's direct phone number is +122445*****
What schools did Jeff Gloyer attend?
Jeff Gloyer attended Ira A. Fulton Schools Of Engineering At Arizona State University, Ira A. Fulton Schools Of Engineering At Arizona State University.
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Jeff Gloyer has interest in Automation, Alternative Energy, Automotive Design.
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Jeff Gloyer has skills like Technical Writing, Team Leadership, Hardware Diagnostics, Electrical Diagnosis, Electrical Troubleshooting, Troubleshooting, Electro Mechanical Troubleshooting, Printed Circuit Board Manufacturing, Soldering, Oscilloscope, Multimeter, Power Supplies.
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