Fresenius-Kabi USA – Sr Construction Project Manager

- A new sterile injectable 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
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- Main responsibilities
- - Technical and commercial lead in all construction areas (facilities, utilities, critical utilities, architectural, mechanical, electrical, HVAC, clean room,..)
- - Communicate, plan, and organize effectively with colleagues, staff, management, architects, engineers, outside contractors and regulatory agencies.
- - Manage a variety of projects at one time and bring them to completion on time, under budget, and safely
- - Develop project funding strategies and prepare Capital Project Appropriation (CPA requests.) CAPEX
- - Providing direction required for compliance with State and local Building Codes, Department of Environmental Protection, USDA, FDA and OSHA regulations

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

Main responsibilities:
  • Technical and commercial lead in all construction areas (facilities, utilities, critical utilities, architectural, mechanical, electrical, HVAC, clean room,..)
  • Communicate, plan, and organize effectively with colleagues, staff, management, architects, engineers, outside contractors and regulatory agencies.
  • Manage a variety of projects at one time and bring them to completion on time, under budget, and safely
  • Develop project funding strategies and prepare Capital Project Appropriation (CPA requests.) CAPEX
  • Providing direction required for compliance with State and local Building Codes, Department of Environmental Protection, USDA, FDA and OSHA regulations

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