GxP IT Systems Support Specialist

We are seeking a GxP IT Systems Support Specialist to serve as the technical owner for assigned regulated systems. This role is responsible for ensuring system performance, security, and compliance with GxP and 21 CFR Part 11 requirements. The ideal candidate brings hands-on system administration experience within a regulated life sciences environment and a strong foundation in data integrity and validation practices.

Responsibilities

• Serve as the primary IT technical point of contact for assigned GxP computerized systems, ensuring availability, reliability, and compliant configuration.
• Administer user access including provisioning, deprovisioning, periodic access reviews, role/permission management, audit trail verification, and time synchronization controls.
• Maintain system configurations in alignment with approved configuration specifications and site governance standards.
• Troubleshoot system and application issues through the IT ticketing system; coordinate with internal IT teams and vendors for triage, root cause analysis, patches, upgrades, and service requests.
• Document incidents, investigations, resolutions, and system updates in accordance with site procedures.
• Author and maintain configuration specifications, system build/restore documentation, SOPs, and work instructions related to GxP system administration.
• Execute IT activities under approved change controls within the QMS and ensure appropriate documentation and evidence are captured.
• Support Computer System Validation (CSV) activities including development and execution of test scripts and IQ/OQ/PQ documentation.
• Plan and support system upgrades, patching, and maintenance activities, including impact assessments and rollback planning.
• Manage system backups, restoration processes, and periodic disaster recovery testing to meet retention and compliance requirements.
• Implement and maintain baseline security controls for systems and infrastructure hosting GxP applications in coordination with cybersecurity standards.
• Partner with business and functional stakeholders to address system issues, evaluate enhancements, and implement approved improvements aligned with operational needs.

Qualifications

• Bachelor's degree in IT, Computer Science, Life Sciences, or related field (or equivalent experience).
• 3+ years of system administration experience.
• 3+ years supporting GxP-regulated applications in a life sciences environment.
• Hands-on experience administering regulated platforms such as Veeva Vault, Oracle Argus, ArisGlobal (ArisG) or similar GxP systems.
• Working knowledge of GxP regulations, 21 CFR Part 11, and data integrity principles (ALCOA+).
• Experience supporting change management processes and Computer System Validation (CSV).

Skills Required
21 Cfr Part 11, System Administration