Fresenius Kabi USA, LLC
DIRECTOR, MAINTENANCE & ENGINEERING
Fresenius Kabi USA, LLC, Grand Island, New York, United States
Job Summary
Leads the Site Engineering and Maintenance teams. Responsible for ensuring that the facility and equipment are kept up-to-date and in good working order. Responsible for strategic, capital and facility planning. Responsible for ensuring the facility and equipment are in compliance with cGMPs.
Hourly Range: $142,000 - $200,000 Annually
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Responsibilities
Direct Engineering and Maintenance functions of GI facility
Lead projects such as the design of manufacturing plants, manufacturing lines and utility systems.
Lead the startup of new processes and technologies.
Manage the preparation and approval of validation protocols for critical equipment and/or processes.
Review final documentation packages for all major systems at the plant including, but not limited to Utility systems, filling operations, packaging operations, dry heat sterilization/depyrogenation, steam sterilizers and process washers.
Lead the design and construction of new and renovated facilities.
Manage company capital and expense budgets.
Develop, organize and lead staff.
Lead projects to continuously improve processes.
Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP's and governmental regulations.
Directly responsible for maintaining facility and systems compliance and operation.
Directly assures compliance to project schedules to meet production requirements and launch of new products.
Promotes continual improvement taking accountability for the effectiveness of the Environmental/Energy Management System.
Responsible for ensuring Health, Safety and Environmental requirements are adhered to.
Ensure department personnel are aware of Fresenius Kabi's Environmental and Energy Management System including Environmental and Energy Policy.
Responsible for ensuring that Health, Safety and Environmental requirements are met under the requirements of ISO 14001 Environmental Management System and ISO 50001 Energy Management System.
Requirements
BS in an Engineering discipline required
10 years Pharmaceutical experience required
Must be knowledgeable in all plant systems and processes
Must demonstrate strong leadership skills
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution
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Hourly Range: $142,000 - $200,000 Annually
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Responsibilities
Direct Engineering and Maintenance functions of GI facility
Lead projects such as the design of manufacturing plants, manufacturing lines and utility systems.
Lead the startup of new processes and technologies.
Manage the preparation and approval of validation protocols for critical equipment and/or processes.
Review final documentation packages for all major systems at the plant including, but not limited to Utility systems, filling operations, packaging operations, dry heat sterilization/depyrogenation, steam sterilizers and process washers.
Lead the design and construction of new and renovated facilities.
Manage company capital and expense budgets.
Develop, organize and lead staff.
Lead projects to continuously improve processes.
Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP's and governmental regulations.
Directly responsible for maintaining facility and systems compliance and operation.
Directly assures compliance to project schedules to meet production requirements and launch of new products.
Promotes continual improvement taking accountability for the effectiveness of the Environmental/Energy Management System.
Responsible for ensuring Health, Safety and Environmental requirements are adhered to.
Ensure department personnel are aware of Fresenius Kabi's Environmental and Energy Management System including Environmental and Energy Policy.
Responsible for ensuring that Health, Safety and Environmental requirements are met under the requirements of ISO 14001 Environmental Management System and ISO 50001 Energy Management System.
Requirements
BS in an Engineering discipline required
10 years Pharmaceutical experience required
Must be knowledgeable in all plant systems and processes
Must demonstrate strong leadership skills
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution
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