Fresenius Kabi – Upgrade of existing production lines for aseptic fillings

Led the full lifecycle of a technical construction project while maintaining communication with key stakeholders. Designed and implemented project funding strategies and developed Capital Project Appropriation (CPA requests) CAPEX. Guided activities to ensure adherence with State and local building codes, Department of Environmental Protection, USDA, FDA, and OSHA regulations.
A new sterile inject-able manufacturing area will be constructed in Fresenius Kabi US, Grand Island, building 4, with modernization of an existing plant by demolition and restructuring the existing architectural environment completely to fit to the scope with objective of transferring aseptic filling, including terminally sterilized filling, from Building 1 to Building 4 in order to use the most current filling technologies. The building 4 manufacturing area will consist of the following major components: – Formulation area with fixed product path, automated WFI dosing and increased automation – Dedicated parts and stopper preparation area with washing machine and vacuum autoclave – Two liquid filling lines and one liquid/lyo filling line, using isolators and VHP technology – Integrated vial washers and depyrogenation tunnels on all filling lines – Integrated capping with vision system – Automated lyophilizer loading and unloading – Automated inspection and packaging on the two liquid-only fill lines
• Spearheaded the construction of a new sterile injectable manufacturing areas in Fresenius Kabi US, Grand Island, building 4, with modernization of an existing plant (65 director employees and contractors).
• Completed a $550M USD project on time and budget.
• Successfully took over project as the sixth project manager when previous managers failed to push the project as expected.