Steven has 20 years of engineering and manufacturing experience including system design, specification, procurement, supplier audits, factory acceptance testing, start-up, system troubleshooting and on-site construction support. Experience includes bioprocess systems, pharmaceuticals, disposable process systems, high purity utility systems, secondary manufacturing, RABS/isolators, packaging, material handling and warehousing. Finishing operations experience includes custom design of equipment for novel drug delivery technologies, robotic systems, potent compound handling, oral solid dosage, large and small volume aseptic fill, lyophilization, terminal sterilization and final packaging. His hands-on experience includes working with an on-site team to implement GMP compliance upgrades to building systems and utilities, in response to an FDA consent decree. Completed training through the Lean Enterprise Institute in Lean Implementation and Value Stream Mapping.Primary focus for the past 3 years has been containment and sterile processing facilities. Recent project work includes automated vial inspection upgrade, bulk sterile antibiotic facility design and isolator evaluation and selection, clinical filling operations using isolators and robotics for aseptic handling, vaccine fill finish facility including prefilled syringe line and multi-dose vials.