Lead IT Systems Engineer - GXP Systems

Title: Lead IT Systems Engineer – GxP Systems

Location: Plantation, FL

Industry: Pharmaceutical / Life Sciences

Experience: 5+ years in IT Infrastructure | 2+ years in GxP-regulated environments

Job Summary:

We are seeking an experienced Lead IT Systems Engineer – GxP Systems to lead day-to-day IT operations at a pharmaceutical site in Coral Springs, Florida. This is a hands-on role for an IT professional with strong infrastructure, networking, laboratory systems, and GxP compliance experience.

The ideal candidate will work independently, troubleshoot complex technical issues, support regulated laboratory systems, and collaborate with QA, CSV, vendors, and business stakeholders to maintain reliable, compliant, and audit-ready IT operations.

Roles & Responsibilities:

• Lead day-to-day site IT operations, including end-user support, incident management, and technical escalations.
• Administer and troubleshoot Windows Server, Active Directory, Microsoft 365, VMware, and Nutanix environments.
• Support network infrastructure, including Juniper switches, VLANs, routing, DNS, DHCP, and wireless connectivity.
• Provide IT support for Waters Empower, chromatography data systems (CDS), and laboratory instrument-connected systems.
• Ensure compliance with cGMP, FDA 21 CFR Part 11, ALCOA+ data integrity principles, and applicable site SOPs.
• Collaborate with QA and CSV teams on system validation, change controls, deviations, CAPAs, periodic reviews, and audit readiness.
• Manage IT asset inventories, system documentation, administrative access, hardware installations, and technology upgrades.
• Coordinate vendor activities, mentor junior IT personnel, and drive technical issues through resolution.
• Support infrastructure projects, cybersecurity initiatives, backup and disaster recovery, and critical after-hours incidents.

Required Qualifications:

• Bachelor's degree in IT, Computer Science, Engineering, or a related field preferred.
• 5+ years of experience in IT infrastructure and end-user support.
• 2+ years of experience supporting GxP-regulated systems in pharmaceutical, biotechnology, medical device, or similar regulated environments.
• Hands-on experience with Windows Server, Active Directory, Microsoft 365, virtualization, and enterprise networking.
• Experience supporting laboratory applications, preferably Waters Empower or similar chromatography data systems.
• Knowledge of Computer System Validation (CSV), cGMP, FDA 21 CFR Part 11, data integrity, and audit support.
• Strong troubleshooting, documentation, communication, and independent problem-solving skills.