Manager, Operational Technology & Manufacturing Systems

Axogen•Vandalia, OH

10d•$113,903 - $142,378•Onsite

About The Position

The Manager, Operational Technology & Manufacturing Systems 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

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.

Nice To Haves

Preferred knowledge of GxP, 21 CFR Part 11, validation, electronic records, manufacturing applications, low-voltage infrastructure, wireless networking, and OT cybersecurity.

Responsibilities

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.