Contract Packaging for Medical Devices. Opening US operations for well-known Swiss company, Fruh Verpackungstechnik AGPackaging components include double-sterile barriers such as tubes, pouches, and blistersCustom packaging designed to fit customer supplied medical devices, including protective packaging, compliant labeling, and sterilization

Leading facility projects for new processes, improvements, and capital projects. Responsible for multi-million dollar manufacturing tranfers including build out, equipment installation and process validation.

Responsible for Packaging and Labeling for a medical device manufacturer and contract packaging: GMP compliance - ISO 11607. Select packaging materials -- pouches, trays, cartons, envelopes for medical device sterilization and distribution. Versed in ASTM package integrity testing standardsResponsible for label design and content to meet FDA requirements. Work with R&D to provide unique packaging for in-house products.Work with customers to develop their specifications or provide input and options for their products.Manage staff of engineers and technicians responsible for package integrity validations, transportation validations, budgeting, specifying and installing new equipment, maintaining existing equipment, process improvementsLean Six Sigma Green Belt

Manufacturer of chromatography columns and provider of contract services for the pharmaceutical industry. Duties include various and diverse responsibilities: Facility Management: Complete responsibility for facility operations and maintenanceInitiate, budget, and track capital improvements Prepare scope, bid and award engineering and construction projectsMaintain yearly facility budget and control costsAward and monitor planned maintenance contracts Adapted initial facility design and construction to meet actual useRe-sized chiller to increase efficiency, reliability, and energy savingsInvestigate and implement green initiative for energy savingsOperational Excellence/LEAN Advocate: Trained in LEAN Level 1 operational excellence.Participated in Kaizen projects to reduce duration in cleaning of process equipment by 50%Facilitated Value Stream Mapping Team to reduce contract service time and confusionConducted Root Cause Analysis to determine reason for mislabeling of productRegulatory Compliance: Responsible for adherence to DOT/IATA, OSHA, and EPA regulations Write/conduct in-house training for regulatory requirements including OSHA and RCRA Work with Environmental Health and Safety Contractors for compliance and testingPlan and execute company safety meetings, peer inspections and accident investigations

Consulting firm specializing in Project and Construction Management as Owner's Representatives for new and fit-out construction. Create schedules, budgets, plan review to assist clients who do not have the staff on-site to handle new construction projects and relocations.Worked with chemical/pharmaceutical companies, universities (library and dormatory projects), and property management groups.

Design and project management of pilot plant and R&D scale processing for the chemical industry. Also, facility and infrastructure improvement projects.

Fabrication firm specialized in pressure vessels, heat exchangers, and pressure piping.