AxoGen, Inc.
Sr. Manager, Facilities
AxoGen, Inc., Vandalia, Ohio, United States, 45377
Axogen is hiring for a Sr. Facilities Manager in Vandalia, OH!
Job Summary of the Sr. Facilities Manager
The primary responsibility of this position is to provide operational support and leadership and direction to the facility and maintenance personnel. Responsibility includes the overall facility support for all operations and to assist in the project management in the build out of the new facility.
Axogen, a rapidly growing biotech company focused on human tissue regeneration and specializing in peripheral nerve repair, is looking for a talented and motivated Facilities Manager to work in our Dayton, OH facility.
The Sr. Facilities Manager will oversee all facility functions including HVAC, electrical, water system, distribution equipment, buildings, and grounds, improve and maintain all facility process equipment and infrastructure, utility, mechanical and security systems. This individual will also be responsible for managing key GMP programs such as installation, commissioning, calibration, maintenance, and lifecycle management. A portion of the facility is a clean-room environment that will need to be maintained to the correct standards. This position may also be asked to utilize their expertise as needed should facility issues arise in our 2 other locations in the US.
Requirements of the Sr. Facilities Manager
High school diploma required. Degree in related discipline preferred.
Minimum 10 years of experience working in medical or regulated manufacturing operation
Advanced understanding of contamination control topics including cleanroom operation, HEPA filtration, disinfection, gowning, and proper material/personnel flow preferred
Ability to prepare and manage budgets
Able to interpret P&IDs, mechanical, electrical, plumbing architectural and construction drawings.
Must have strong understanding of Mechanical, Electrical and Plumbing (MEP) and utility systems as well as commissioning, qualification, and validation activities
Experience working to regulatory standards like FDA, Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP) Strong organizational skills, oral and written communication skills, and team player attitude
Demonstrated ability to lead and manage teams, contractors, and 3rd party service providers
Successful track record for hands on leadership, facilitation, and project management
Working knowledge of cGMP equipment such as compressed air systems, DI/RO purified water system and clean steam generation, chilled water systems, boilers, building management systems
Knowledge of cleanroom environments
Understanding of HVAC systems for medical device or pharmaceutical facilities
Experience with building automation, monitoring systems, asset management systems, security systems
Responsibilities of the Sr. Facilities Manager
The specific duties of the Sr. Facilities Manager include but are not limited to:
Lead facility and maintenance team to achieve operational objectives and compliance.
Leader for educating on and supporting safety, quality and environmental compliance.
Partner with Quality, Manufacturing, Finance and other functional groups onsite and at other locations to improve processes and asset performance.
Support process investigations supporting CAPA requirements as it relates to facility or maintenance activities and processes.
Manage a building management system to ensure the facility maintains critical operating parameters.
Interfaces with federal, state, and local regulatory authorities to manage projects requiring regulatory approval including the FDA, EMA, OSHA, EPA, and local authorities.
Management of outside service providers and contractors, energy conservation, asset management, reliability centered maintenance, resource planning, life cycle costing, and identification and use of industry best practices.
Set direction and manage the electronic preventative maintenance and calibration system and timely execution of activities to maintain the facility and equipment.
Represents Facilities and Engineering function during FDA and other regulatory agency inspections by explaining design features of facility, utilities, and qualification methods.
Write and/or assist in writing SOP's, Change Orders and Deviations based on solid understanding of regulatory requirements for the facility operations.
Physical Requirements
The work is medium work which requires exerting up to 30 pounds of force and occasionally exerting up to 60 pounds of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Additionally, the work requires the following physical abilities: mental acuity, visual acuity, walking, repetitive motion, speaking, talking, hearing, and typing.
Working & Environmental Conditions
Work involves everyday risks or discomforts which require normal safety precautions typical of such places as offices or meeting and training rooms, e.g., use of safe workplace practices with office equipment, avoidance of trips and falls, and observance of fire and building safety regulations. AxoGen facilities include controlled environment where gowning is required and facilities that are controlled by HVAC.
Frozen products require handling of dry ice with applicable PPE.
Location
913 Industrial Drive Place
Vandalia, OH
45377
#LI-AC1
Benefits/Compensation
#J-18808-Ljbffr
Job Summary of the Sr. Facilities Manager
The primary responsibility of this position is to provide operational support and leadership and direction to the facility and maintenance personnel. Responsibility includes the overall facility support for all operations and to assist in the project management in the build out of the new facility.
Axogen, a rapidly growing biotech company focused on human tissue regeneration and specializing in peripheral nerve repair, is looking for a talented and motivated Facilities Manager to work in our Dayton, OH facility.
The Sr. Facilities Manager will oversee all facility functions including HVAC, electrical, water system, distribution equipment, buildings, and grounds, improve and maintain all facility process equipment and infrastructure, utility, mechanical and security systems. This individual will also be responsible for managing key GMP programs such as installation, commissioning, calibration, maintenance, and lifecycle management. A portion of the facility is a clean-room environment that will need to be maintained to the correct standards. This position may also be asked to utilize their expertise as needed should facility issues arise in our 2 other locations in the US.
Requirements of the Sr. Facilities Manager
High school diploma required. Degree in related discipline preferred.
Minimum 10 years of experience working in medical or regulated manufacturing operation
Advanced understanding of contamination control topics including cleanroom operation, HEPA filtration, disinfection, gowning, and proper material/personnel flow preferred
Ability to prepare and manage budgets
Able to interpret P&IDs, mechanical, electrical, plumbing architectural and construction drawings.
Must have strong understanding of Mechanical, Electrical and Plumbing (MEP) and utility systems as well as commissioning, qualification, and validation activities
Experience working to regulatory standards like FDA, Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP) Strong organizational skills, oral and written communication skills, and team player attitude
Demonstrated ability to lead and manage teams, contractors, and 3rd party service providers
Successful track record for hands on leadership, facilitation, and project management
Working knowledge of cGMP equipment such as compressed air systems, DI/RO purified water system and clean steam generation, chilled water systems, boilers, building management systems
Knowledge of cleanroom environments
Understanding of HVAC systems for medical device or pharmaceutical facilities
Experience with building automation, monitoring systems, asset management systems, security systems
Responsibilities of the Sr. Facilities Manager
The specific duties of the Sr. Facilities Manager include but are not limited to:
Lead facility and maintenance team to achieve operational objectives and compliance.
Leader for educating on and supporting safety, quality and environmental compliance.
Partner with Quality, Manufacturing, Finance and other functional groups onsite and at other locations to improve processes and asset performance.
Support process investigations supporting CAPA requirements as it relates to facility or maintenance activities and processes.
Manage a building management system to ensure the facility maintains critical operating parameters.
Interfaces with federal, state, and local regulatory authorities to manage projects requiring regulatory approval including the FDA, EMA, OSHA, EPA, and local authorities.
Management of outside service providers and contractors, energy conservation, asset management, reliability centered maintenance, resource planning, life cycle costing, and identification and use of industry best practices.
Set direction and manage the electronic preventative maintenance and calibration system and timely execution of activities to maintain the facility and equipment.
Represents Facilities and Engineering function during FDA and other regulatory agency inspections by explaining design features of facility, utilities, and qualification methods.
Write and/or assist in writing SOP's, Change Orders and Deviations based on solid understanding of regulatory requirements for the facility operations.
Physical Requirements
The work is medium work which requires exerting up to 30 pounds of force and occasionally exerting up to 60 pounds of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Additionally, the work requires the following physical abilities: mental acuity, visual acuity, walking, repetitive motion, speaking, talking, hearing, and typing.
Working & Environmental Conditions
Work involves everyday risks or discomforts which require normal safety precautions typical of such places as offices or meeting and training rooms, e.g., use of safe workplace practices with office equipment, avoidance of trips and falls, and observance of fire and building safety regulations. AxoGen facilities include controlled environment where gowning is required and facilities that are controlled by HVAC.
Frozen products require handling of dry ice with applicable PPE.
Location
913 Industrial Drive Place
Vandalia, OH
45377
#LI-AC1
Benefits/Compensation
#J-18808-Ljbffr