Senior GxP Systems Engineer - San Diego

- Act as the primary technical owner for Industrial Control Networks (ICN), ensuring proper segmentation, security controls, resilience, and availability - Lead operational support for infrastructure platforms including VMware, Veeam, Cisco switching, and firewalls - Manage connectivity for scientific instruments, ensuring data collection, storage, backup, and archival align with data integrity and regulatory standards - Ensure IT readiness for IND-enabling activities and GMP laboratory operations - Oversee systems in GxP- and SOX-controlled environments, ensuring compliance with FDA regulations and internal quality standards - Ensure adherence to 21 CFR Part 11, data integrity principles (ALCOA+), and GDPR regulations where applicable - Apply and enforce GAMP 5 principles throughout the system lifecycle, including validation strategies - Lead and review Computer Systems Validation (CSV) deliverables including URS, FRS/FS, and traceability matrices - Act as a senior IT representative during audits, inspections, and quality reviews, providing support as needed - Facilitate remediation planning, CAPAs, and continuous improvement initiatives related to regulated systems - Provide oversight of Active Directory services, including user provisioning and security governance - Implement role-based access control and segregation of duties to maintain compliance - Manage third-party vendor relationships for GMP infrastructure and ICN environments - Establish and maintain compliant SOPs, Work Instructions, Policies, and controlled user forms - Support regulated laboratory applications such as LIMS and SDMS in a secondary engineer capacity