IT/OT Senior Lab Specialist

Scorpion Therapeutics; Durham (NC); On-site; USD 110,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior IT/OT Lab Specialist to lead the strategy, implementation, and lifecycle management of computerized laboratory systems in GMP and non-GMP environments at our Durham, NC site.

You will ensure reliability, compliance, and operational excellence for pharmaceutical manufacturing, including system design, vendor coordination, change controls, and GxP documentation; support inspections and audits.

Qualifications

• B.S. in Engineering, Computer Science, IT, or related field.
• 8+ years experience in pharmaceutical or biopharmaceutical lab operations.
• Experience with lab system installation, configuration, and maintenance in GMP settings.
• Knowledge of FDA 21 CFR part 11 and GMP systems.

Responsibilities

• Design, configure, install, and maintain lab instrumentation/software.
• Coordinate vendor interactions and manage maintenance work orders.
• Lead laboratory change controls and prepare/review GxP documentation.
• Support inspections and audits.

Skills

Lab systems

GxP compliance

Documentation

Vendor liaison

Education

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

Job description

Role

Senior IT/OT Lab Specialist responsible for leading the strategy, implementation, and lifecycle management of computerized laboratory systems in GMP and non-GMP environments.

Objectives

ensure lab systems' reliability, compliance, and operational excellence to support pharmaceutical manufacturing and development.

Responsibilities

• design, configure, install, and maintain lab instrumentation/software, coordinate vendor interactions, manage maintenance work orders, lead laboratory change controls, prepare and review GxP documentation, and support inspections and audits.
• support operational improvements, develop SOPs, and provide technical support for lab system issues.

Requirements

B.S. in Engineering, Computer Science, IT, or related field; 8+ years (or 12+ years in lieu of degree) experience in pharmaceutical or biopharmaceutical lab operations; expertise with lab system installation, configuration, and maintenance in GMP settings; knowledge of FDA 21 CFR part 11, GMP systems, and operational excellence tools.

Preferred

ability to support contingency plans, work under pressure, and possibly travel up to 10%.

High-Value

focus on regulated laboratory environments, computerized systems, and compliance with industry standards.

Work setup

likely on-site with potential for rotating on-call duties.