Atlanta, Georgia, United States
Mechanical Engineer with skills geared to support and provide Validation and Quality services within the Pharmaceutical industry. Knowledgeable of the validation lifecycle. Team oriented, responsible, under pressure work effectivity are some core competencies that will help to develop a professional assertiveness towards company goals. Experienced in the execution of protocols and reports for Validations, Qualifications and Commissioning documents, SOP’s (Standard Operating Procedures), and investigations related to new and existing facilities. Knowledge on Kaye Validator for validation studies.
On-site technical lead for commissioning and qualification of utility and process systems (gas detection, hot/chilled water, compressed air) on the Amgen Ohio capital-expansion program — one of the largest pharmaceutical manufacturing investments underway in the U.S. - Primary technical liaison to construction and equipment vendors, verifying installations meet owner standards and resolving issues directly with vendor field teams. - Daily hands-on work in KNEAT (paperless digital-validation software), authoring and executing qualification protocols. - Coordinate deliverables, schedules, and turnover across engineering, construction, and commissioning workstreams using Smartsheet and Autodesk Construction Cloud (ACC).
Led the end-to-end test-material program supplying design, FAT, and C&Q activities for the new Amgen Ohio packaging lines — a cross-functional initiative spanning 4 Amgen sites across the U.S., Puerto Rico, and Ireland. - Directed production of syringes in 2023–2024, breaking a record volume never previously achieved at the facility, by orchestrating fill and packaging operations across two manufacturing facilities. - Coordinated a 9-person team across 7 functions (media sciences, supply chain, dispensing, fill, shipping, material movement) with no direct authority, driving alignment through influence. - Managed global shipping logistics to vendor sites across 6 countries (Canada, Switzerland, Denmark, Italy, Germany) and multiple Amgen sites. - Owned the multi-year fill-run scheduling process across two facilities.
Deployed as the technical resource to 9+ client companies across the U.S. and Puerto Rico — earning client trust and repeat engagements while working hands-on with the equipment, instruments, and software that vendors sell into pharma: CO₂ incubators, controlled-rate freezers, autoclaves, data loggers (Kaye, Ellab, Sensitech), PLC/HMI automation, and HVAC/clean-steam utilities. Clients included Amgen, CytoImmune Therapeutics, Poseida Therapeutics, McNeil Consumer Healthcare, Xellia Pharmaceuticals, Bausch & Lomb, and Alcon. - Developed and executed IQ/OQ/PQ and thermal-validation protocols across a wide range of process and lab equipment. - Led a thermal-mapping study for 24 CO₂ incubators (clinical use) with wireless data loggers. - Led a thermal-mapping study for autoclaves (clinical use) with wireless data loggers and Kaye Validator loggers. - Executed CSV protocols for automated systems (Allen-Bradley PLCs, DeviceNet, Wonderware HMI); debugged with system integrators and authored Test Event Reports. - Translated complex technical and compliance requirements for client engineers, quality teams, and leadership.