Lead IT Systems Engineer (Pharma Industry)

Title: Lead IT Systems Engineer – GxP Systems (Pharma Industry)

Location: Plantation, FL

Industry: Pharmaceutical / Life Sciences

Experience: 5+ years in IT Infrastructure | 2+ years supporting GxP-regulated pharmaceutical or life sciences environments

Learn more about the general tasks related to this opportunity below, as well as required skills.

Job Summary:

We are seeking an experienced Lead IT Systems Engineer – GxP Systems to support within a pharmaceutical or life sciences environment . The ideal candidate will have hands-on experience supporting GMP-regulated laboratories, pharmaceutical quality systems, chromatography data systems, and IT infrastructure used in regulated laboratory and manufacturing operations.

This role requires a strong understanding of pharmaceutical IT systems, GxP compliance, computerized system validation (CSV), data integrity, and FDA regulatory expectations. The selected candidate will work closely with Quality Assurance (QA), Computer System Validation (CSV), laboratory operations, QC, and external vendors to maintain validated, secure, reliable, and audit-ready systems supporting pharmaceutical testing and quality operations.

Candidates with direct pharmaceutical, biotechnology, or life sciences industry experience supporting GxP-regulated laboratory systems are strongly preferred.

Roles & Responsibilities:

• Lead day-to-day IT operations supporting pharmaceutical laboratories, quality control (QC) functions, and other GxP-regulated site operations.
• Administer and troubleshoot Windows Server, Active Directory, Microsoft 365, VMware, and Nutanix environments supporting pharmaceutical and laboratory applications.
• Support laboratory IT infrastructure and network connectivity, including Juniper switches, VLANs, routing, DNS, DHCP, and wireless networks used in regulated laboratory environments.
• Provide technical support for Waters Empower, chromatography data systems (CDS), and laboratory instrument-connected systems used in pharmaceutical testing, analytical laboratories, and quality control operations.
• Maintain systems in compliance with cGMP, FDA 21 CFR Part 11, ALCOA+ data integrity principles, and applicable pharmaceutical quality procedures and site SOPs.
• Collaborate with QA, QC, and CSV teams on computer system validation, change controls, deviations, CAPAs, periodic system reviews, and regulatory inspection readiness.
• Support validated system lifecycle activities, including system documentation, access reviews, audit trail considerations, backup verification, and change implementation in accordance with approved procedures.
• Manage IT asset inventories, system configuration documentation, user access privileges, hardware installations, and infrastructure upgrades while maintaining appropriate GxP documentation.
• Coordinate with laboratory instrument vendors, software providers, validation consultants, and internal stakeholders to resolve technical issues affecting regulated systems.
• Provide technical guidance to junior IT personnel and ensure incidents affecting laboratory operations and GxP systems are investigated, documented, and resolved appropriately.
• Support infrastructure upgrades, cybersecurity initiatives, backup and disaster recovery activities, and business continuity for critical pharmaceutical laboratory systems.
• Participate in internal and external audits, regulatory inspections, and compliance assessments by providing technical documentation, system records, and evidence of appropriate IT controls.
• Support critical laboratory system incidents and after-hours escalations to minimize disruption to pharmaceutical testing, quality operations, and regulated business processes.

Required Qualifications:

• Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field preferred.
• 5+ years of experience in IT infrastructure, systems administration, or enterprise IT support, preferably within pharmaceutical, biotechnology, or life sciences organizations.
• Minimum 2+ years of hands-on experience supporting GxP-regulated systems in a pharmaceutical, biotechnology, medical device, or other regulated life sciences environment.
• Direct experience supporting pharmaceutical QC laboratories, analytical instruments, laboratory information systems, or chromatography data systems is strongly preferred.
• Hands-on experience with Waters Empower or similar chromatography data systems used in regulated pharmaceutical laboratories.
• Strong knowledge of Windows Server, Active Directory, Microsoft 365, VMware or Nutanix virtualization, and enterprise network infrastructure.
• Working knowledge of cGMP, FDA 21 CFR Part 11, ALCOA+ data integrity principles, and pharmaceutical quality system requirements.
• Experience collaborating with QA and CSV teams on validation documentation, change controls, deviations, CAPAs, periodic reviews, and audit preparation.
• Experience supporting laboratory instruments, regulated applications, and IT systems used in pharmaceutical quality control or analytical testing operations. xhyhwjd
• Strong troubleshooting, documentation, communication, vendor coordination, and independent problem-solving skills.