Compunnel Inc. · 12 hours ago
Information Technology System Engineer -- KUMDC5729024
Coral Springs, FL
Contract
Onsite
Senior Level
$65/hr - $75/hr
5+ years expCompunnel Inc. is seeking a Computer Systems Validation (CSV) Engineer to provide hands-on IT support for computerized systems used in GxP operations at their Coral Springs site. The role involves system administration, technical troubleshooting, and maintaining compliance-aligned configurations while partnering with Quality/CSV to ensure the validated state of systems is upheld.
Information Technology & Services
Hiring Manager
Parag Patel
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)
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
Preferred
Familiarity with GAMP 5
Company
Compunnel Inc.
Compunnel Inc. is where AI-native solutions meet human ingenuity, helping enterprises reimagine talent, technology, and growth.
5001-10000 employees
H1B Sponsorship
Compunnel Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2276)
2024 (1682)
2023 (1992)
2022 (2366)
2021 (2223)
2020 (2220)
Funding
Current Stage
Late StageLeadership Team
Andy Gaur
Founder, Chairman & CEO
Karthik Natarajan
Executive VP & CTO
Company data provided by crunchbase