Senior IT Systems Engineer (GxP)

Role Summary

The Senior 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 serves as a supporting and backup engineer for regulated laboratory applications including LIMS and SDMS. Location: Supporting three sites in San Diego; onsite.

Responsibilities

• Serve as the primary technical owner for Industrial Control Networks (ICN), ensuring segmentation, security controls, resilience, and availability for validated and non-validated domains.
• Manage scientific instrument connectivity, data collection, data storage, backup, retention, and archival processes in accordance with data integrity and regulatory requirements.
• Ensure ongoing IT readiness for IND-enabling activities, GMP laboratory operations, and future program scale.
• Provide senior-level ownership for systems operating within GxP- and SOX-controlled environments, aligning with FDA regulatory expectations and internal quality standards.
• Ensure compliance with 21 CFR Part 11, data integrity principles (ALCOA+), and GDPR where applicable.
• Apply and enforce GAMP 5 principles across the system lifecycle, including risk-based validation strategy, periodic review, and system retirement.
• Lead and review Computer Systems Validation (CSV) deliverables including URS, FRS/FS, DDS/HDS/SDS, IQ/OQ/PQ, and traceability matrices.
• Serve as a senior IT representative during internal audits, regulatory inspections, and quality reviews, supporting application owners as needed.
• Drive remediation planning, CAPAs, and continuous improvement initiatives related to regulated systems.
• Provide senior oversight of Active Directory services including user provisioning, security group governance, and Group Policy administration for regulated and non-regulated domains.
• Enforce role-based access control, segregation of duties, and least-privilege principles to support compliance and audit readiness.
• Lead third-party vendor relationships supporting GMP infrastructure and ICN environments, ensuring vendor qualification and inspection readiness.
• Establish and maintain compliant SOPs, Work Instructions, Policies, and controlled user forms within the Quality Management System (QMS).
• Support regulated laboratory applications including LIMS and SDMS as a secondary engineer, providing backup coverage, infrastructure support, and validation assistance in coordination with application owners.
• Support application owners as a contributing Change Control participant for LIMS, SDMS, and other regulated laboratory systems.

Qualifications

• Required: At least 5 years of hands-on experience with VMware, Veeam, Cisco networking, and firewalls.
• Required: Significant experience supporting GxP-regulated laboratory and/or manufacturing environments within an FDA-regulated organization.
• Required: Advanced expertise in Computer Systems Validation (CSV) and FDA regulations, including 21 CFR Part 11.
• Required: Strong working knowledge of GAMP 5 and risk-based validation methodologies.
• Required: Experience supporting ICN environments and collaborating with LIMS, SDMS, and QC laboratory system owners.
• Preferred: Experience supporting GMP clinical manufacturing environments.
• Preferred: Experience working within an enterprise QMS (e.g., Veeva).
• Preferred: Prior involvement in FDA inspections or regulatory submissions.
• Preferred: Experience providing secondary or backup support for validated laboratory applications.

Education

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or equivalent experience