Speaker Biography
Steven Wisniewski
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, health care, and specialty manufacturing industries. Wisniewski has more then 30 years experience in the pharmaceutical, biotech, 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 served on the ISPE board of directors beginning in 1982, and was chairman of the board in 1991. Currently, Wisniewski is chairman of the ISPE Community of Practice for Commissioning and Qualification, and was on the ISPE task team that developed the ASTM E2500 Verification Standard, and serves on the Task Teams that drafted ISPE new Verification (C&Q) Baseline® Guide 12, and the C&Q Good Practice Guide in progress.