Director of Engineering
BioPharm Engineered Systems
James Nardone is the Director of Engineering at BioPharm Engineered Systems and is responsible for managing the Engineering/Design Department and coordinating the activities of the Operations team. In this role he works to strengthen the organization through quoting of projects while overseeing the development of the department. He defines the work methodology for the execution of projects with focus on providing quality deliverables on schedule and within budget constraints.
James has spent the past 20 years overseeing the conceptualization, design, Manufacturing, start-up, and commissioning of Bioprocess and clean utility systems, while working on projects within the biopharmaceutical, pharmaceutical and clean industrial industries. His main role includes; technical leader on projects, consisting of managing teams and executing conceptual, process, piping, and automation design. He has provided process designs for all areas of clean market and utility systems and has extensive experience with modular system design, aseptic processing techniques, and implementing single use technologies into the manufacturing process systems.
James is a proud father of 3 young boys whom he coaches in multiple sports in his spare time.
James holds a BS in Mechanical Engineering and is very knowledgeable about FDA, ASME, BPE, CE, PED, CRN, codes and standards.