Senior IT/OT Lab Systems Lead (GMP)

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

Job summary

Novartis seeks an IT/OT Senior Lab Specialist to lead design, configuration, and maintenance of computerized laboratory systems in GMP and non-GMP settings. You will drive reliability, compliance, and continuous improvement across a highly regulated manufacturing and development environment.

The role requires extensive experience with lab instrumentation software, regulatory knowledge, CAPA and change control, and collaboration with cross-functional teams to optimize lab performance and ensure

Qualifications

• B.S. degree in Engineering, Computer Science, IT or related technical field.
• 8+ years’ work experience in pharmaceutical or biopharmaceutical-based lab operations (12 years in equivalent role).
• Excellent oral and written communication skills.
• Experience leading teams installing, configuring and maintaining lab systems in a GMP environment.
• Experience implementing computerized systems in a corporate network environment.
• Knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• Knowledge of Quality by Design, Six Sigma, and operational excellence tools.
• Experience working with and leading 3rd parties (in-sourcing and outsourcing).

Responsibilities

• Lead design, configuration, installation, and maintenance of lab software/hardware across GMP/non-GMP environments.
• Ensure high availability of lab instruments; coordinate with vendors for architecture and connectivity.
• Manage work orders for maintenance and audit-related activities.
• Act as SME during health authority and internal inspections for compliance.
• Track CAPA closures and lead instrument change controls.
• Prepare and archive GxP/non-GxP documents (URS, FS, DDS/HDS/SDS).
• Engage with internal partners on priorities and timelines.
• Support operational excellence and quality initiatives; update SOPs and procedures.
• Provide IT/OT team support and 24x7 site coverage as needed.

Skills

Lab systems

GMP compliance

FDA 21 CFR 11

Quality by Design

Vendor management

CAPA management

Cross-functional leadership

Change control

Education

Bachelor’s degree in Engineering/CS/IT

Job description

Novartis seeks an IT/OT Senior Lab Specialist to lead design, configuration, and maintenance of computerized laboratory systems in GMP and non-GMP settings. You will drive reliability, compliance, and continuous improvement across a highly regulated manufacturing and development environment.

The role requires extensive experience with lab instrumentation software, regulatory knowledge, CAPA and change control, and collaboration with cross-functional teams to optimize lab performance and ensure