Manager, Operational Technology & Manufacturing Systems

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 youll love working atAxogen:

• Friendly openandfunteam culturethat values uniqueperspectives
• Company-wide dedicationto profoundly impacting patients lives
• Comprehensive high-quality benefitspackage effective on date of hire
• Educationalassistanceavailable for all employees
• Matching 401(k)retirementplan
• Paid holidaysincluding floating holidaysto 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 Operational Technology & Manufacturing Systems

The Manager Operational Technology & Manufacturing Systems serves as the senior technology leader for Axogens 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 Operational Technology & Manufacturing Systems

• Bachelors 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 Manager Operational Technology & Manufacturing Systems

The specific duties of the Manager Operational Technology & Manufacturing Systems include but are not limited to:

• Serve as the senior onsite IT and Operational Technology (OT) leader and primary liaison between plant leadership Corporate IT and business stakeholders. Translate operational priorities risks strategic initiatives and business needs into aligned technology roadmaps support strategies and execution plans.
• Lead and develop the OT support team establishing priorities workload plans escalation processes support coverage documentation standards and service expectations while coordinating the efforts of Corporate IT personnel application owners vendors contractors and site resources regardless of reporting relationships.
• Oversee operational support maintenance and lifecycle management of manufacturing technology systems. Maintain visibility to preventive maintenance backups incidents changes CAPAs MOC activities projects and support activities ensuring work is properly prioritized documented executed and audit ready.
• Direct technology planning and execution for site growth infrastructure initiatives and digital transformation efforts. Manage technology vendors and implementation partners while coordinating resources schedules dependencies testing installations turnover activities and technology investments that improve operational efficiency data integrity traceability and business processes.
• Partner with Production Quality Validation Engineering Facilities and other stakeholders to govern technology changes new system implementations validation activities CAPA resolution and change control processes. Ensure alignment with enterprise architecture cybersecurity requirements IT policies and regulatory expectations while supporting audit readiness and compliance.
• Collaborate with Quality Validation and Corporate IT to maintain GxP Part 11 data integrity cybersecurity disaster recovery business continuity and risk management programs across the OT environment.
• Establish and maintain documentation governance and lifecycle standards ensuring inventories diagrams procedures runbooks access records maintenance histories validation documentation and technical records remain current accurate and audit ready.
• Manage vendor performance service levels budgets contracts renewals capital planning forecasting and technology investment priorities in partnership with the Senior Director of IT.

Location

913 Industrial Park Dr Vandalia OH 45377

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Benefits/Compensation

Company Statements

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.

As AI is becoming a common tool throughout the application process we want to be clear about its appropriate use at Axogen. Using AI to support resume writing research or interview preparation is perfectly acceptable provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process however it is important that the ideas communication and work you share reflect your own voice experiences and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness celebrates your individuality and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen.

No agency solicitation. We kindly request that recruiting agencies staffing firms and thirdparty vendors do not contact us regarding this posting. Unsolicited résumés will not be considered.