Senior Lab IT/OT Systems Lead

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

Job summary

Novartis is seeking an IT/OT Senior Lab Specialist to lead strategy, implementation, and lifecycle management of computerized laboratory systems across GMP and non-GMP environments. You will partner with cross-functional teams to optimize lab performance, drive continuous improvement, and support a highly regulated manufacturing and development setting.

Responsibilities include leading installation and maintenance of lab software/hardware, ensuring high instrument availability, and guiding CAPA

Qualifications

• B.S. degree in Engineering, Computer Science, IT or related technical field.
• 8 years' work experience in pharmaceutical or biopharmaceutical lab operations (12 years alternative).
• 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 (both in-sourcing and outsourcing).

Responsibilities

• Lead design, configuration, installation, and maintenance of lab instrumentation/equipment software and hardware.
• Ensure high availability of lab instruments/equipment; coordinate with vendors.
• Manage work orders for maintenance activities on lab equipment.
• Participate as an SME in health authority and internal inspections ensuring compliance.
• Track and drive CAPA closures; lead instrument change controls.
• Prepare and review GxP and non-GxP instrument documentation.
• Lead discussions with internal partners on priorities and timelines.
• Support operational excellence and continuous improvement with Quality.
• Create/update SOPs to drive efficiency and compliance; investigate non-conformances.
• Provide IT/OT support; 24x7 site-based operations including on-call rotations.

Skills

Lab systems leadership

GMP experience

FDA 21 CFR Part 11

Quality by Design

Six Sigma

Vendor/3rd-party management

Communication skills

IT/OT collaboration

Education

B.S. degree in Engineering/CS/IT or related

Tools

Instrument software management

Job description

Novartis is seeking an IT/OT Senior Lab Specialist to lead strategy, implementation, and lifecycle management of computerized laboratory systems across GMP and non-GMP environments. You will partner with cross-functional teams to optimize lab performance, drive continuous improvement, and support a highly regulated manufacturing and development setting.

Responsibilities include leading installation and maintenance of lab software/hardware, ensuring high instrument availability, and guiding CAPA