Senior OT & Manufacturing Systems Manager

Axogen, Inc.; Vandalia (OH); On-site; USD 114,000 - 142,000; Full time

Benefits offered by this job

Health

Dental

Vision

Matching 401K

Paid Time Off

9 Paid Holidays + 3 Floating Holidays

Dependent Care FSAs

Medical FSAs

Tuition Reimbursement

Paid Parental Leave

Paid Caregiver Leave

Basic Life Insurance

Supplemental Life Insurance

Employee Stock Purchase Plan

Disability Insurance

Job summary

Axogen, Inc. seeks a Manager of Operational Technology & Manufacturing Systems to lead on-site OT/IT for the Ohio manufacturing facility. You will align technology with manufacturing needs, supervise a technical team, and coordinate with Corporate IT and vendors.

Reporting to the Senior Director of IT, you will drive regulatory compliance, project execution, and infrastructure modernization across OT and manufacturing systems, ensuring continuous, audit-ready operations.

Qualifications

• Bachelor's degree or 8+ years of relevant experience in information systems, CS, engineering, or biotech.
• Minimum 7 years supporting enterprise/OT/manufacturing systems in regulated environments.
• Minimum 3 years leading technical teams and managing vendors in manufacturing contexts.
• Experience with regulated production environments, validation, change control, and documentation compliance.
• Strong communication and relationship-management across plant leadership, IT, and external partners.
• Preferred knowledge of GxP, 21 CFR Part 11, data integrity, and OT cybersecurity.

Responsibilities

• Serve as senior onsite OT and IT leader, liaison between plant leadership and Corporate IT.
• Translate operational priorities into technology roadmaps and execution plans.
• Lead OT support team, establish priorities, coverage, and documentation standards.
• Oversee maintenance and lifecycle management of manufacturing technology systems.
• Ensure audit readiness, regulatory compliance, and IT policy alignment.
• Collaborate with Quality, Validation, Engineering, Facilities to govern changes and new implementations.

Skills

Strong communication

Prioritization

Relationship management

Follow-through

Vendor management

Cross-functional collaboration

Education

Bachelor's degree in Information Systems, Computer Science, Engineering, Biotechnology, or related

Tools

GxP knowledge

21 CFR Part 11

OT cybersecurity

Job description

Axogen, Inc. seeks a Manager of Operational Technology & Manufacturing Systems to lead on-site OT/IT for the Ohio manufacturing facility. You will align technology with manufacturing needs, supervise a technical team, and coordinate with Corporate IT and vendors.

Reporting to the Senior Director of IT, you will drive regulatory compliance, project execution, and infrastructure modernization across OT and manufacturing systems, ensuring continuous, audit-ready operations.