IT/OT Lab Systems Engineer — GMP & Compliance

Novartis Group Companies; Durham (NC); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis Group Companies is seeking an IT/OT Lab Specialist based in Durham, NC, onsite. You will support laboratory computerized systems, ensure regulatory compliance, and collaborate with cross-functional teams to sustain reliable instrument performance.

The role requires a bachelor’s degree in a technical field and 5+ years in pharma/biopharma lab operations, with GMP system experience and strong vendor management skills.

Qualifications

• Bachelor’s degree in a technical field with GMP or regulated environment experience.
• Experience with laboratory computerized systems and regulatory compliance.
• Strong communication and cross-functional collaboration skills.
• Experience with vendor relationships and third-party service providers.
• Familiarity with FDA regulations, 21 CFR Part 11.

Responsibilities

• Support design, installation, configuration, and maintenance of lab instruments, software and hardware.
• Ensure high availability and reliable performance of computerized systems.
• Collaborate with vendors and stakeholders to implement system architectures.
• Execute maintenance activities, audits, and lifecycle documentation.
• Manage change controls, CAPAs, and GMP documentation.
• Support FDA inspections and internal audits for assigned labs.
• Drive continuous improvement for efficiency, compliance, and system performance.

Skills

Automation

Automation Testing

Debugging

Programming Languages

Python

Robotics

Software Testing

Technical Support

Test Automation

Education

Bachelor's degree in Engineering, Computer Science, IT or related field

Job description

Novartis Group Companies is seeking an IT/OT Lab Specialist based in Durham, NC, onsite. You will support laboratory computerized systems, ensure regulatory compliance, and collaborate with cross-functional teams to sustain reliable instrument performance.

The role requires a bachelor’s degree in a technical field and 5+ years in pharma/biopharma lab operations, with GMP system experience and strong vendor management skills.