IT/OT Lab Engineer - GMP Compliance & Automation

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

Job summary

Novartis in Durham, NC is seeking an IT/OT Lab Specialist to support laboratory computerized systems and equipment, ensuring compliant, high-availability operations that sustain scientific innovation.

You will work with cross-functional teams to implement system architectures, manage change controls, and assist FDA inspections, all within GMP/21 CFR 11 frameworks. This onsite role requires a Bachelor's in engineering or related field and 5+ years in pharmaceutical lab operations.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field.
• 5+ years of pharmaceutical or biopharmaceutical laboratory operations experience.
• Experience installing, configuring, and maintaining laboratory computerized systems in a GMP environment.
• Experience implementing computerized systems within a corporate network infrastructure.
• Knowledge of FDA regulations, including 21 CFR Part 11, and other applicable GMP requirements.
• Strong written and verbal communication skills with the ability to collaborate across diverse teams.
• Experience managing vendor relationships and supporting third-party service providers.
• Proven troubleshooting and problem-solving abilities in complex, regulated operational environments.

Responsibilities

• Support the design, installation, configuration, and maintenance of laboratory instruments, software, and associated hardware.
• Ensure high availability and reliable performance of laboratory computerized systems and equipment.
• Partner with vendors and internal stakeholders to implement effective system architectures and connectivity solutions.
• Execute maintenance activities, user reviews, audit trail reviews, and other system lifecycle requirements.
• Manage change controls, CAPAs, and system documentation in accordance with GxP requirements.
• Support FDA inspections, internal audits, and compliance activities across assigned laboratory areas.
• Drive continuous improvement initiatives that enhance operational efficiency, compliance, and system performance.

Skills

Automation

Automation Testing

Debugging

Programming Languages

Python

Robotics

Software Testing

Technical Support

Test Automation

Education

Bachelor's degree

Job description

Novartis in Durham, NC is seeking an IT/OT Lab Specialist to support laboratory computerized systems and equipment, ensuring compliant, high-availability operations that sustain scientific innovation.

You will work with cross-functional teams to implement system architectures, manage change controls, and assist FDA inspections, all within GMP/21 CFR 11 frameworks. This onsite role requires a Bachelor's in engineering or related field and 5+ years in pharmaceutical lab operations.