Manager, Operational Technology & Manufacturing Systems at Axogen in Vandalia, OH

Job description

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 Manager IT, GxP Systems & Compliance The Manager IT, GxP Systems & Compliance serves as the senior technology leader for Axogen's Ohio manufacturing facility, providing leadership for onsite technology personnel and acting as the primary liaison between plant leadership and Corporate IT. Reporting to the Senior Director of IT, this role oversees and coordinates Operational Technology, infrastructure, cybersecurity, manufacturing applications, vendors, and enterprise IT resources to ensure reliable operations, regulatory compliance, project execution, and operational excellence. The Manager partners closely with Manufacturing, Quality, Engineering, Facilities, Laboratory, and Operations leaders to align technology priorities with business needs, coordinate activities with production schedules, remove barriers to execution, and minimize operational disruption. The role also leads technology planning team and vendor coordination for facility expansion, workforce growth, infrastructure modernization, and manufacturing system initiatives, ensuring technology capabilities support both current operations and long-term business objectives. Requirements of the Manager IT, GxP Systems & Compliance Bachelor's degree in Information Systems, Computer Science, Engineering, Biotechnology, or a related discipline; or 8 years of related experience will be considered. Minimum 7 years supporting enterprise, manufacturing, operational technology, computerized, or regulated systems. Minimum 3 years of experience leading technical teams, managing vendor relationships, coordinating cross-functional resources, or directing technology projects in a manufacturing or regulated environment. Experience with regulated production environments, system implementations, vendor management, facility technology, change control, validation support, and compliance documentation. Strong communication, prioritization, relationship-management, and follow-through skills across plant leadership, operational teams, IT, contractors, and vendors. Preferred knowledge of GxP, 21 CFR Part 11, validation, electronic records, manufacturing applications, low-voltage infrastructure, wireless networking, and OT cybersecurity. Responsibilities of the ManagerIT, GxP Systems & Compliance The specific duties of the ManagerIT, IT Systems & Compliance include but are not limited to: Serve as the senior onsite IT and Operat