Advanced Barrier Concepts, Inc. – Cary, North Carolina
(1994 – Present)
President / Technical Director: Co-founded Advanced Barrier Concepts, Inc. in order to provide direct technical assistance to the pharmaceutical and biotechnology industries regarding process equipment design, hydrogen peroxide gas decontamination process, and the integration of process equipment with isolator systems for sterility testing and advanced aseptic processing applications. Expertise used for more than 10 aseptic filling line projects located in the United States, Canada, and Europe. Responsibilities include project management, equipment / process design reviews, equipment manufacturer selection, document generation (validation master plans, user requirement specifications, functional requirement specifications, detailed design specifications, bid packages, FAT/SAT/IQ/OQ/PQ protocols, SOPs, final reports), protocol execution, and regulatory support regarding process application and product licensing.
AMSCO International – Apex, North Carolina – Cary, North Carolina
(1991 – 1994)
Manager, Systems Engineering - Product Commercialization Group: Directed five customer support systems engineers and four current product engineering technical staff members. Responsible for developing a market for three models of a hydrogen peroxide gas biodecontamination system via applications development, customer technical support, and product modifications.
Project Manager, Research and Development: Managed a development team of six personnel. Accountable for planning, scheduling, and directing the engineering design and development efforts for new hydrogen peroxide gas biodecontamination products. Coordinated the combined efforts of Marketing, Manufacturing, Quality Assurance and Service Engineering to define new product development objectives.
Project Engineer, Research and Development: Directed a four-person team responsible for new product development and design. Accountable for managing projects within approved budget constraints and projected time schedules.
W.C. Little Engineering – Erie, Pennsylvania
(1983 – 1991)
Engineering Consultant: Owner and president of an engineering firm specializing in the design of hydraulic and mechanical systems. Responsible for the design and development of custom engineered systems to satisfy specific client needs.
Bucyrus-Erie Company, Construction Machinery Div. – Erie, Pennsylvania
(1973 – 1983)
Quality Control Manager: Directly responsible to the Plant Manager and the Division General Manager for special projects. Managed a department of six exempt, five non-exempt and twenty-four hourly personnel. Accountable for planning, organizing and directing the quality function in the machine, welding and assembly operation for backhoes, hydraulic excavators and cranes with annual sales in excess of $50 million.
Quality Control Supervisor: Supervised eleven indirect hourly personnel. Responsible for the quality acceptance level in the material receiving, assembly, and shipping departments and for the hydraulic testing of a backhoe/loader product line. Co-designed a testing facility for in-house receiving inspection of hydraulic pumps and motors.
Manufacturing Resident Engineer: Responsible for maintaining a liaison between engineering and manufacturing concerning problems created by design errors or manufacturing process limitations.
Gannon University – Erie, Pennsylvania Completed all course work for a M.B.A, 1979.
Gannon University – Erie, Pennsylvania Bachelor of Mechanical Engineering (B.M.E.)1973.
U.S. Patent No. 5,275,310: Vented, Non-Reusable, Multi-Dose Cartridge
U.S. Patent No. 5,534,221: Device and System for Sterilizing Objects
International Society for Pharmaceutical Engineering (ISPE)
Parenteral Drug Association (PDA)