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.
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.

Location

913 Industrial Drive Place, Vandalia, OH 45377

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Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range$122,386—$152,982 USD

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.