Lead IT Systems Engineer (GxP)

Role Summary

The Lead IT Systems Engineer (GxP) is a senior technical role responsible for the architecture, operation, and compliance of regulated laboratory and manufacturing IT/OT systems across multiple operational sites. This position provides primary ownership of GMP infrastructure environments and acts as a supporting and backup engineer for regulated laboratory applications including LIMS and SDMS. The role focuses on sustaining and scaling existing GMP laboratory and clinical manufacturing operations, addressing operational and compliance risks related to system redundancy, availability, and regulatory scope. The Lead Systems Engineer operates with a high degree of autonomy and partners closely with Quality, Manufacturing, Laboratory, and IT stakeholders to ensure validated, compliant, and inspection-ready environments aligned with FDA regulations and GAMP 5 principles. Location: On-site across multiple sites.

Responsibilities

• Serve as the p...