Senior IT Systems Engineer (GxP)

- Take ownership for the architecture and compliance of GMP infrastructure across multiple operational sites - Provide senior-level support and lifecycle management for compliant IT and OT infrastructure in laboratory and clinical manufacturing settings - Lead operational tasks related to infrastructure platforms including VMware, Veeam, Cisco networking, and firewalls - Directly manage scientific instrument connectivity and data processes ensuring regulatory compliance - Maintain IT readiness for IND-enabling activities and GMP laboratory operations - Oversee systems in GxP- and SOX-controlled environments aligned with regulatory expectations - Ensure adherence to 21 CFR Part 11 and data integrity principles - Implement GAMP 5 principles throughout the system lifecycle - Supervise and review Computer Systems Validation (CSV) documentation - Act as a senior IT contact during audits, inspections, and quality reviews - Foster remediation planning, CAPAs, and initiatives for ongoing improvement - Provide oversight of Active Directory services for user management and security - Enforce access control and compliance principles - Manage third-party vendor relations for GMP infrastructure and ICN - Create and uphold compliant SOPs, Work Instructions, Policies, and user forms within the Quality Management System - Support regulated applications such as LIMS and SDMS in a secondary capacity as needed