GxP IT Systems Lead – API Automation

Novo Nordisk A/S; West Lebanon (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

Novo Nordisk Site New Hampshire in West Lebanon focuses on manufacturing life-saving therapies and operates with a patient-centric mindset. The role independently manages API automation and IT systems throughout their lifecycle, ensuring compliance and robust change control.

Responsibilities include validation coordination, system security controls, documentation, training, and coordinating upgrades while maintaining GxP and data integrity standards.

Qualifications

• Bachelor’s degree in Information Technology or related field required; 5+ years IT systems management experience in pharma/GxP preferred.
• Experience supporting automation/IT systems and batch processes is a plus.
• Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11 and/or PIC/S Annex 11 is advantageous.

Responsibilities

• Manage requirements and controls for assigned systems, ensuring data integrity, audit trails, and retention.
• Coordinate validation testing (FAT/SAT/IQ/OQ/PQ) and lifecycle plans for system upgrades and retirements.
• Lead risk assessments, change control, and validation activities for assigned systems.

Skills

IT systems management

GxP compliance

Regulatory audits

System validation

COBIT/ITIL/GAMP

Data integrity

Documentation

Incident resolution

Risk assessment

Education

Bachelor’s degree in Information Technology or related field

Tools

FAT/SAT/IQ/OQ/PQ

IT security controls

Job description

Novo Nordisk Site New Hampshire in West Lebanon focuses on manufacturing life-saving therapies and operates with a patient-centric mindset. The role independently manages API automation and IT systems throughout their lifecycle, ensuring compliance and robust change control.

Responsibilities include validation coordination, system security controls, documentation, training, and coordinating upgrades while maintaining GxP and data integrity standards.