Lead Sterilization Engineering group as part of Core Team that develops and validates market changing pharmaceuticals and medical products. Support worldwide expansion and manufacturing of Moist Heat, Radiation, Parametric Release and emerging technologies. Compose NDA and ANDA sections. Mitigate risk of existing products and suppliers through audits, Six Sigma processes, training, and change control management.

Lead corporate validation and new product/process development engineering team. Ensure best in class processes while meeting regulatory, quality, and project requirements. Support operations worldwide with troubleshooting, and value improvements utilizing DMAIC methods. Write sections of regulatory submissions for Drugs and Devices. Subject matter expert in Sterilization Process Engineering. Develop and manage engineers. Perform FAT/IQ/OQ/PQ of new and existing equipment. Train facility based resources on standards and best practices to ensure fast response times and information flow.

Coordinate Sterility Assurance Activities as member of core product development teams. Maintain specifications and standard operating procedures. Plan, schedule and lead project assignments. Devises new approaches to complex problems through technical principals and skills. Study director for validation protocols. Use statistical methods to implement process improvements in production and design. Support supplier changes for existing products and perform risk mitigation and analysis. Write sections of 510(k) and New Drug Submissions. Winner of R&D Achievement Award. Manage Pilot Plant. Supervise Technicians and Engineer.

Designed new products in Advanced Engineering Group. Designed components of FDA and ISO 13485 regulated class II medical devices. Over 1500 hours of Pro/Engineer experience. Worldwide patents granted or pending. Performed and interpreted FE analysis. Conducted system and component level FMEAs. Partnered with Strategic Sourcing group to optimize supply chain and implement statistical based specifications. Completed documentation and audit of prototypes to ensure FDA compliance.