GMP Lab IT/OT Systems Lead

Healthcare Businesswomen’s Association; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Benefits offered by this job

Health benefits

401(k) with company contribution and l

Paid time off

Job summary

Novartis is seeking an IT/OT Senior Lab Specialist to lead strategy and lifecycle management of computerized laboratory systems across 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 where your work impacts patients and business outcomes.

You will manage lab instrument software and hardware, ensure high availability, participate in inspections, and drive

Qualifications

• Excellent oral and written communication skills.
• Experience leading teams installing, configuring and maintaining lab systems in a GMP environment.
• Knowledge of FDA regulations (21 CFR Part 11) and GMP systems.
• Knowledge of Quality by Design and operational excellence tools.
• Experience working with and leading 3rd parties (in-sourcing and outsourcing).

Responsibilities

• Lead design, configuration, installation, and maintenance of lab instrumentation software and hardware.
• Ensure high instrument availability and proper architectures/connectivity.
• Manage work orders to complete maintenance activities on lab equipment.
• Participate as SME in health authority and internal inspections for compliance.
• Drive CAPA closeout and lead lab instrument change controls.
• Prepare, review and archive instrument documentation (URS, FS, DDS/SDS).
• Lead discussions with internal partners on priorities and timelines.
• Support quality and continuous improvement in the lab environment.
• Create/ revise SOPs to improve efficiency and compliance.
• Support 24x7 site operations including on-call responsibilities.

Skills

Communication skills

GMP systems experience

FDA 21 CFR part 11 knowledge

Quality by Design knowledge

Vendor management

Education

B.S. in Engineering/CS/IT

Job description

Novartis is seeking an IT/OT Senior Lab Specialist to lead strategy and lifecycle management of computerized laboratory systems across 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 where your work impacts patients and business outcomes.

You will manage lab instrument software and hardware, ensure high availability, participate in inspections, and drive