Onsite IT/OT Lab Specialist — GMP Systems, Durham

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

Benefits offered by this job

Health benefits

401(k) with company match

Generous time off

Job summary

Novartis in Durham, NC, onsite, seeks an IT/OT Lab Specialist to support laboratory computerized systems and related hardware, ensuring reliability and compliance with regulatory requirements.

The role involves collaboration with vendors and internal teams to design and maintain system architectures, execute maintenance, perform audits, and drive process improvements to optimize efficiency and compliance in a GMP setting.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field.
• 5+ years of pharmaceutical or biopharmaceutical laboratory operations experience, or equivalent industry 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.

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

Communication

Regulatory compliance

Cross-functional collaboration

Troubleshooting

Vendor management

Education

Bachelor's degree in Engineering/Computer Science/Information Technology

Tools

Laboratory IT systems

GxP-compliant LAB software

Job description

Novartis in Durham, NC, onsite, seeks an IT/OT Lab Specialist to support laboratory computerized systems and related hardware, ensuring reliability and compliance with regulatory requirements.

The role involves collaboration with vendors and internal teams to design and maintain system architectures, execute maintenance, perform audits, and drive process improvements to optimize efficiency and compliance in a GMP setting.