Lupin Pharmaceuticals · 11 hours ago
GxP IT Systems Support / CSV Technical Contractor
Coral Springs, FL
Full-time, Contract
Onsite
Senior Level
5+ years expLupin Pharmaceuticals is a fast-growing company focused on manufacturing and research and development in the pharmaceutical sector. They are seeking a GxP IT Systems Support / CSV Technical Contractor to provide hands-on IT support for computerized systems used in GxP operations, ensuring compliance and reliability of these systems.
BiotechnologyPharmaceuticalRobotics
Responsibilities
Serve as the IT technical point of contact (SME) for assigned GxP computerized systems (e.g., laboratory and manufacturing support systems), ensuring availability, reliability, and compliance-aligned configuration
Perform system administration tasks, including user/account provisioning and periodic access reviews; role/privilege configuration; audit trail enablement/verification; time synchronization checks; and controlled parameter settings per approved specifications
Coordinate troubleshooting and resolution of system issues by engaging internal IT teams and reaching out to system vendors for triage, root-cause investigation, patches/hotfixes, and service requests; document incident details and outcomes per site procedures
Draft, update, and maintain Configuration Specifications (CS), system build/restore instructions, and other technical documentation that defines approved system settings and architecture for the site
Draft, update, and maintain site IT SOPs and work instructions related to GxP system administration (e.g., account management, backup/restore, audit trails, cybersecurity controls, patching, and disaster recovery), ensuring alignment with site governance
Manage and execute backups, restores, and disaster recovery activities for assigned systems (including periodic verification/testing) and ensure backup schedules and retention meet approved requirements
Support controlled technical changes through the site Quality Management System (QMS): initiate/execute IT tasks under approved change controls, provide impact/risk input as requested, and ensure evidence is captured for configuration changes
Implement and maintain baseline security controls for servers/workstations hosting GxP systems (e.g., endpoint protection, hardening settings, account policies) in coordination with site cybersecurity standards and approved system constraints
Plan and perform system and infrastructure upgrades (hardware/software) for assigned systems in coordination with vendors, operations, and QA/CSV; ensure technical readiness, rollback planning, and documentation updates
Qualification
Required
Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field (or equivalent relevant experience)
Minimum of 5 years' experience supporting GxP-regulated IT systems (system administration and technical remediation) in a pharmaceutical/biotech or similarly regulated environment
Hands-on experience with vendor coordination, incident troubleshooting, and controlled change execution in a regulated setting
Working knowledge of GxP principles, data integrity expectations, and applicable regulations/standards (e.g., FDA 21 CFR Part 11; familiarity with GAMP 5 is a plus)
Strong documentation skills, including authoring/updating configuration specifications and IT SOPs
Ability to manage multiple priorities, communicate clearly with technical and non-technical stakeholders, and work effectively on-site
Company
Lupin Pharmaceuticals
Lupin Pharmaceuticals is a generic pharmaceutical company.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Bob Hoffman
Chief Commercial Officer (CCO)
Shahin Fesharaki
Global Chief Scientific Officer
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