Systems Engineer

IT/OT Systems Engineer

Location: Morrisville, NC
Employment Type: Full-Time Contract
Hours of Work: Monday-Friday; 8:30 am-4:30 pm

FLSA Exemption Status : Exempt

Kelaca is seeking an IT/OT Systems Engineer for our Client Partner in Morrisville, NC , a growing gene therapy organization operating in FDA/GMP-regulated manufacturing environments. This role is ideal for a technical leader who thrives at the intersection of enterprise IT infrastructure, operational technology, and regulated biotechnology operations.

The IT/OT Systems Engineer plays a pivotal role in designing, optimizing, implementing, and maintaining the infrastructure that supports both corporate systems and FDA/GMP manufacturing environments. You will lead modernization initiatives, drive technical decisions for critical systems, and partner closely with Manufacturing, Quality, Information Security, and external vendors to ensure stability, security, and audit readiness across multiple sites.

This role requires deep technical expertise, strategic thinking, and a steady execution rhythm, someone who brings structure, clarity, and reliability to a complex and growing environment.

What You’ll Do

Infrastructure Architecture & Engineering

• Design, build, and oversee scalable IT and OT infrastructure supporting business, laboratory, and GMP manufacturing systems.
• Lead modernization efforts across Azure, hybrid cloud, and on-prem environments, including hyper-converged infrastructure and Azure Local clusters.
• Engineer highly available Windows Server environments using Azure Local/Hyper-V platforms and Storage Spaces Direct.
• Evaluate emerging technologies and guide architecture decisions aligned with business and regulatory requirements.

Identity, Access, & Core Services

• Administer and optimize Active Directory/Entra ID, Group Policy, DNS/DHCP, and Conditional Access.
• Lead identity governance and domain architecture improvements across IT and OT systems.
• Implement and test robust backup, disaster recovery, and business continuity strategies across all IT/OT environments.

Operational Technology & Manufacturing Systems

• Collaborate with OT teams and vendors to support manufacturing execution systems, SCADA, data historians (e.g., PI System), and other specialized platforms.
• Help ensure infrastructure supporting GxP systems meets validation, change control, and documentation standards.

Network Engineering

• Design and improve IT/OT network segmentation aligned with GMP and Purdue Model practices.
• Configure switching, routing, firewalls, and security appliances to support secure and compliant operations.
• Implement enterprise monitoring, alerting, and analytics solutions.

Remote Access & Virtual Infrastructure

• Engineer and optimize RDS/VDI platforms for corporate users and manufacturing floor access.

Documentation, Audits & Leadership

• Produce clear technical documentation, SOPs, architecture diagrams, and runbooks.
• Support audit response, deviation investigations, and regulatory inspections as needed.
• Provide technical mentorship to junior IT/OT staff and coordinate cross-functional problem solving.

What Success Looks Like

• High availability and security across core IT/OT infrastructure.
• Reliable disaster recovery and strong documentation practices.
• Clear, structured communication in audit, leadership, and technical contexts.
• Autonomous execution with an ownership mindset — balanced with strong cross-functional collaboration across sites.

Qualifications

Required

• Bachelor’s degree in Computer Science, IT, Engineering, or equivalent experience.
• 10+ years of progressive experience in enterprise infrastructure or systems engineering.
• Hands-on expertise with:
  • Windows Server (2016–2025), Hyper-V, Azure Local, Storage Spaces Direct
  • Active Directory / Entra ID, DNS, DHCP, GPO design
  • Azure cloud services, hybrid cloud, networking, backup/DR, VPN tunnels
  • IT/OT network segmentation, firewalls, and security controls; Purdue Reference Model Familiarity
• Experience supporting FDA-regulated or GxP environments. Emphasis on documentation, validation, and audit readiness
• Strong project management skills with demonstrated ability to lead modernization initiatives in multi-site environments

Nice to Have

• Exposure to manufacturing platforms such as MES, SCADA, and PI System.
• Familiarity with validation, change control, or infrastructure qualification.
• Experience with enterprise monitoring and analytics platforms.
• Background supporting or modernizing OT networks.
• Relevant certifications strongly preferred: MCSE/MCSA, Azure Administrator/Solutions Architect, CCNA/CCNP, GICSP, or equivalent

Soft Skills & Working Style

This environment benefits from someone who:

• Works independently with calm, deliberate decision-making/problem solving.
• Collaborates fluently across IT, OT, Manufacturing, and Quality.
• A strategic mindset who not only solves today’s problems but sets up for future success.
• Communicates clearly in writing and during escalations or audits.
• Brings an ownership mindset with low-ego partnership.
• Acts as a steady specialist who blends thoughtful planning with pragmatic delivery.

Why This Role Matters

This hire enables the organization to scale its infrastructure and support growing manufacturing operations across multiple sites. You will help modernize systems, strengthen security, and ensure the technical foundation is reliable, compliant, and future-ready.

Your work directly impacts product development, manufacturing continuity, audit outcomes, and the organization’s ability to serve patients through next-generation gene therapies.

Join Us

If you’re an experienced IT/OT engineer who thrives in regulated biotech environments and enjoys building modern, reliable infrastructure, we’d love to connect. Apply through Kelaca to learn more about this opportunity.