Senior Facilities Manager

5 days ago

Vandalia, Ohio, United States AxoGen Full time
About AxoGen

AxoGen is a leading biotechnology company dedicated to revolutionizing the science of nerve repair. Our mission is to positively impact lives by restoring function and quality of life to patients with physical damage or discontinuity to peripheral nerves.

Job Summary

The Senior Facilities Manager will be responsible for providing operational support and leadership to the facility and maintenance personnel. This includes overall facility support for all operations, project management in the build out of the new facility, and ensuring compliance with regulatory standards such as FDA, Good Manufacturing Procedures (GMP), and Good Documentation Procedures (GDP).

Key Responsibilities
  • 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.
  • 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.
Requirements
  • 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, GMP, and 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.
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.

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