IT/OT Lab Systems Lead - GMP Compliance & Optimization

Novartis; North Carolina; On-site; USD 109,000 - 202,000; Full time

Benefits offered by this job

401(k) with company match

Comprehensive benefits

On-site work

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 partner with cross-functional teams to ensure reliability, compliance, and operational excellence, supporting 24x7 site-based operations and on-call duties.

Responsibilities include leading lab instrument software deployment, maintaining high availability, and driving CAPA closure, change controls, and

Qualifications

• Bachelor’s degree required in engineering, CS, IT or related technical field.
• 8+ years in pharmaceutical/biopharmaceutical lab operations or 12+ years equivalent.
• Experience leading teams installing, configuring and maintaining lab systems in GMP environments.
• Experience implementing computerized systems in corporate networks.
• Knowledge of FDA regulations, especially 21 CFR Part 11, and GMP systems.
• Knowledge of Quality by Design, Six Sigma and operational excellence tools.
• Experience working with and leading 3rd party vendors (in-sourcing/outsourcing).

Responsibilities

• Lead design, configuration, installation, and maintenance of lab instrumentation software and related hardware.
• Ensure high availability of lab instruments and collaborate with vendors on architectures and connectivity.
• Manage work orders, maintenance activities, and CAPA tracking to ensure on-time completion.
• Serve as SME in inspections, ensuring compliance with procedures.
• Prepare and review GxP and non-GxP instrument documentation.
• Collaborate with internal partners on priorities, timelines, and information sharing.

Skills

Oral and written communication

GMP lab systems

Computer networked systems

21 CFR Part 11

Quality by Design

Six Sigma/operational excellence

Vendor/third-party management

Education

B.S. in Engineering or Computer Science or related field

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 partner with cross-functional teams to ensure reliability, compliance, and operational excellence, supporting 24x7 site-based operations and on-call duties.

Responsibilities include leading lab instrument software deployment, maintaining high availability, and driving CAPA closure, change controls, and