Senior IT/OT Lab Systems Lead (GMP)

Novartis; Durham (AR); On-site; USD 109,000 - 202,000; Full time

Job summary

Novartis is seeking an IT/OT Senior Lab Specialist to lead the strategy, implementation, and lifecycle management of computerized laboratory systems across GMP and non‑GMP environments. You will collaborate with process engineers and quality teams to ensure system reliability, regulatory compliance, and operational excellence, delivering improvements that impact product quality and patient outcomes.

This role requires strong communication and the ability to lead cross‑functional projects and

Qualifications

• Bachelor's degree in Engineering, Computer Science, IT, or related technical field.
• 8+ years in pharma/biopharma lab operations (or 12 years in equivalent).
• Experience leading labs installing, configuring and maintaining GMP lab systems.
• Knowledge of FDA 21 CFR part 11 and GMP systems.
• Experience leading 3rd party vendors and CAPA processes.

Responsibilities

• Lead design, configuration, installation, and maintenance of lab instrumentation software and related hardware.
• Ensure high availability of lab instruments and connectivity with vendors as needed.
• Manage work orders and ensure on-time completion of maintenance activities.
• Participate as SME in health authority and internal inspections ensuring regulatory compliance.
• Drive CAPA closure, track investigations, and lead instrument change controls.
• Prepare, review, and archive GxP and non-GxP instrument documentation (URS, FS, DDS/SDS).
• Lead discussions with business partners on priorities, timelines, and information sharing.
• Support 24x7 site operations including on-call responsibilities.

Job description

Novartis is seeking an IT/OT Senior Lab Specialist to lead the strategy, implementation, and lifecycle management of computerized laboratory systems across GMP and non‑GMP environments. You will collaborate with process engineers and quality teams to ensure system reliability, regulatory compliance, and operational excellence, delivering improvements that impact product quality and patient outcomes.

This role requires strong communication and the ability to lead cross‑functional projects and