Senior GxP Systems Engineer

- Serve as the main technical owner for Industrial Control Networks (ICN), ensuring proper security, segmentation, and availability - Lead operational support for infrastructure including VMware, Veeam backup, Cisco networking, and firewalls - Oversee scientific instrument connectivity, data collection, storage, retention, and archival practices in line with data integrity and regulatory standards - Maintain IT readiness for IND-enabling activities and GMP laboratory operations - Ensure systems comply with GxP- and SOX-regulated environments according to FDA expectations and internal quality standards - Enforce compliance with 21 CFR Part 11, data integrity principles (ALCOA+), and GDPR when applicable - Implement and uphold GAMP 5 principles throughout the system lifecycle, including risk-based validation strategies - Review and lead Computer Systems Validation (CSV) documentation and deliverables - Act as a senior IT representative during internal audits, regulatory inspections, and quality reviews - Drive remediation efforts, CAPAs, and continuous improvement initiatives regarding regulated systems - Oversee Active Directory services including user management and security governance for both regulated and non-regulated environments - Enforce access control, segregation of duties, and least-privilege principles for compliance - Manage relationships with third-party vendors supporting GMP infrastructure and ICN - Develop and maintain compliant SOPs, Work Instructions, Policies, and controlled user forms within our Quality Management System (QMS) - Provide secondary support for regulated laboratory applications as a backup engineer