Consultant on process and facilities capital project management and maintenance encompassing engineering design, procurement, construction, commissioning, and training on new installations, renovations, system modifications and upgrades at pharmaceutical facilities. Also, provided support for product and process development operations and quality deviation investigations to improve plant production and operations. Lead cross functional work groups on projects, and drove projects to successful completion as measured by budget, schedule, and quality metrics with satisfied stakeholders. Implemented simultaneous projects of significant complexity. Independently evaluated, selected, and applied both standard and advanced engineering techniques, procedures, and criteria. Utilized stage gate project management methods to complete assignments. Mentored and coached entry level engineers, technicians, and students on principles of good engineering practice. Working on senior projects with local student AIChE chapters: Department of Chemical and Biomedical Engineering (Cleveland State University), and Department of Chemical and Biomolecular Engineering (Case Western Reserve University). Currently a Fellow of the American Institute of Chemical Engineers (AIChE), and serves as the Past Chairman of the Cleveland Section of AIChE.
NOVO NORDISK A/S
Xellia Pharmaceuticals USA, LLC
Associate Project Lead
Accountable for project management and administration of in-house, contracted, and financial resources for the execution of small to mid-sized process improvement projects, related to manufacturing and building services. Responsible for validated and non-validated process optimization, process troubleshooting, development of equipment specifications/upgrades, and the implementation of innovative new quality and compliance approaches for aseptic processes. Application in Facilities involve architectural; HVAC in Grades A through Grade D qualified rooms, controlled not classified rooms, and uncontrolled rooms; Electrical applications with lighting, power distribution, and hazardous area classification; Black Utilities systems of plant steam and condensate, compressed air, and process water; and Clean Utilities systems of Water For Injection, Nitrogen, and High Purity Air. Interfacing with automation of environmental controls of humidity, temperature, pressure, with viable and non-viable particulate control (HEPA and ULPA filtration) through Building Automation Systems for controlled and classified areas.
NOVO NORDISK A/S
Facilities and Utilities Project Manager
Site engineering consultant responsible for project management and administration of in-house, contracted, and financial resources for the execution of small to mid-sized process improvement projects, related to manufacturing and building services. Senior Engineer responsible for validated and non-validated process optimization, process troubleshooting, development of equipment specifications/upgrades, and the implementation of innovative new quality and compliance approaches for aseptic processes. Applications in cGMP FDA and EMA compliant equipment preparation, formulation, sterile filling, and lyophilization processes. With environmental controls of humidity, temperature, and particulates (HEPA and ULPA filtration) through Building Automation System for controlled and classified areas.
BOEHRINGER INGELHEIM GmbH
Ben Venue Laboratories, Inc.
Senior Project Engineer
• Formulations Dept: Specified jacketed pressure vessels; temperature control units; agitation motor drives with impeller duty; as well as nitrogen, compressed air, pressure relief, and flammable vapor systems.
• Sterile Filling Dept: Installed nitrogen systems for product vial headspace oxygen reduction, and zero grade air for a media headspace overlay in simulation runs.
• Freeze Drying Dept: Provided nitrogen, compressed air, vacuum, cooling water, refrigeration, Water-For-Injection, Clean-In-Place, and Steam-In-Place systems support.
• Manufacturing, Science, and Technology Dept: Managed pilot plant project with 2 formulation suites, fill suite, 5 freeze dryer suite, equipment decontamination, and equipment room areas.
• Deviation Investigations: Calculated batch agitation, fluid dynamics, heat transfer or mass transfer to verify if a product quality excursion resulted from a change in a specified parameter in a batch or continuous operation with steady state or unsteady state transition.
• Agency Audit SME: Site Subject Matter Expert for formulation vessels, temperature control units, nitrogen, zero grade air, and compressed air systems. Supported SME on Water-For-Injection and Clean Steam Systems. Audit agencies includ the Food and Drug Administration, FDA; European Medical Agency, EMA; Brazilian Health Surveillance Agency, ANVISA; Pharmaceuticals and Medical Devices Agency of Japan, PMDA; and the Australian Therapeutic Goods Administration, TGA.
• Sustainable Engineer: Report on key performance indicators defined as site energy consumption based on electricity, natural gas, and water utilities. The utility process streams are used to support the manufacture of products on a per vial basis and a per square foot basis of the manufacturing area. Designed and installed water reclaim and energy recovery systems in 3 factories saving $57k annually in each factory.
AECOM (URS Corporation, Washington Group International, Morrison Knusen Corporation, HK Ferguson Company)
Senior Process Engineer
Engineering design and construction operations with process engineering responsibilities. Lead process design of Process Flow Diagrams (PFDs) with material and energy balances for multi-component systems as well as Piping and Instrumentation Diagrams (P&IDs) with loop control diagrams. Lead process team member on HAZOP Analysis of P&ID systems. Utilized ChemCAD, ASPEN, MathCAD, and BioPro Designer simulation systems for design analysis, and MS Project for project monitoring and controls. Lead field process engineer during construction completion and P&ID systems check out. Lead start-up process engineer during commissioning of systems. Primary industries served were Brewing (Anheuser-Busch, Inc.: Fort Collins, CO; Columbus, OH; St. Louis, MO; Houston, TX; Cartersville, GA; and Newark, NJ; as Brewing Expert, Fermentation Expert, and Finishing Expert), Biotechnology (Covance Biotechnology: Fermentation process systems commissioning and validation; Process Validation Lead), and Semiconductors (Hemlock Semiconductor: Lead Process Engineer on multiple HCl Distillation Recovery Area design-construction projects).