Sr. Manager, Facilities & Maintenance

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!  

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. 

 Why you’ll love working at Axogen: 

• Friendly, open, and fun team culture that values unique perspectives 
• Company-wide dedication to profoundly impacting patients’ lives 
• Comprehensive, high-quality benefits package effective on date of hire 
• Educational assistance available for all employees 
• Matching 401(k) retirement plan 
• Paid holidays, including floating holidays, to be used at your discretion 
• Employee Stock Purchase Plan 
• Referral incentive program 

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Sr. Manager, Facilities & Maintenance

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 Vandalia, OH facility.

The 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. Manager, Facilities & Maintenance

• High school diploma required. Degree in related discipline preferred.
• Minimum 10 years of experience working in medical or regulated manufacturing operation
• 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
• Advanced understanding of contamination control topics including cleanroom operation, HEPA filtration, disinfection, gowning, and proper material/personnel flow preferred
  

Responsibilities of the Sr. Manager, Facilities & Maintenance

The specific duties of the Sr. Manager, Facilities & Maintenance include but are not limited to:

• Lead facility and maintenance team to achieve operational objectives and compliance.
• Lead