Gregory Ruklic, Pfizer Global Engineering, formerly with Wyeth Pharmaceuticals Central Engineering, has an extensive background over 25 years in the biopharmaceuticals industry, with automation and integrated MES-related systems design, validation and quality/compliance oversight. Working for Engineering and Quality Unit organizations, Greg has successfully implemented validated manufacturing systems internationally, and has held leadership positions in the development and implementation of site, operating unit and corporate level systems standards and guidance. He is currently USA co-chair of the GAMP MES Special Interest Group, member of the GAMP Americas Leadership Team and contributing author to GAMP publications. Greg has presented at USA and international forums on topics ranging from MES design in support of flex-team based manufacturing, to systemic (built-in) risk management.