Steven Walter is a Lead Process Mechanical Engineer / GMP Technology Specialist at CDI Life Sciences located in Philadelphia, PA. He received his B.S in Operations Management from Pennsylvania State University, and has worked as a Continuous Improvement Analyst and Industrial / Process Mechanical engineer for most of his 16+ year career, all in the microelectronics, plastics and pharmaceutical and biotechnology sectors. His roles included project management, equipment and facility design, lean implementation and equipment procurement / FAT /SAT. Steve has 16 years of engineering and manufacturing experience for a broad variety of projects. His experience includes bioprocess systems, disposable process systems, pharmaceuticals, high purity utility systems, secondary manufacturing, packaging, material handling, and warehousing. Steve’s equipment expertise includes system design, specification, procurement, supplier audits, factory acceptance testing, start-up and system troubleshooting. Steve’s project experience includes operations for microbial fermentation, mammalian cell culture, product recovery, purification, vaccine production, plasma fractionation and blood substitute manufacturing. He has extensive experience in finishing operations, including custom design of equipment for novel drug delivery technologies, potent compound handling, oral solid dosage, large and small volume aseptic fill, lyophilization, terminal sterilization, and final packaging. Steve’s experience also includes design of a fully automated warehouse with a rail guided vehicle system for material handling, filling and packaging. He has also designed several warehouse and security systems for storing narcotic products in compliance with strict DEA requirements. Steve was part of a site based team that implemented facility and system upgrades to biological and finishing operations and pharmaceutical grade utilities, in response to the FDA‘s consent decree of the site. Steve completed training through the Lean Enterprise Institute in Lean Implementation and Value Stream Mapping. ISPE, Lean Enterprise Institute.