Steven J. Wisniewski is Senior Associate and Director of Compliance for Integrated Project Services (IPS), a full-service engineering firm specializing in the delivery of technical complex projects, and that offers complete design/build, commissioning, validation, and FDA compliance services for the pharmaceutical, biotech, healthcare, and specialty manufacturing industries. Wisniewski has more than 30 years experience in the pharmaceutical, biotechnology, and device industries. Prior to joining IPS, he was senior consultant for drug and device associates and has served in senior management roles at Sterling Winthrop and Bausch & Lomb. He has completed a wide variety of pharmaceutical manufacturing, filling and critical support operations to major R&D laboratories, facilities, and upgrades. He holds a BSME from Rensselaer Polytechnic Institute, is a Member of PDA, and an active Member of ISPE. He has served the ISPE board of directors since 1982, and was chairman of the board in 1991. Currently, Wisniewski is chairman of the ISPE Community of Practice for Commissioning and Qualification, and is on the ISPE task teams developing the revised ASTM Verification Standard and the revised C&Q Baseline® Guide.