Lead IT Systems Engineer - GxP Systems

Thor; Town of Florida (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

Thor is seeking a Lead IT Systems Engineer to join its South Florida operation. This hands-on, site-based role demands a high level of IT infrastructure expertise and GxP/regulatory systems knowledge, serving as a senior technical resource on-site.

The position focuses on leading IT operations, supporting Windows Server, AD, M365, virtualization, and enterprise networking, while ensuring compliance with FDA 21 CFR Part 11 and data integrity requirements at a regulated site.

Qualifications

• 5+ years of IT infrastructure / systems support experience.
• 2+ years in a GxP-regulated pharmaceutical, biotech, medical device environment.
• Experience supporting laboratory or chromatography data systems preferred.
• Strong Windows Server, AD, M365 and virtualization knowledge.
• Experience with CSV, cGMP and FDA 21 CFR Part 11.

Responsibilities

• Lead day-to-day IT operations and provide technical support for the site.
• Support Windows Server, Active Directory, Microsoft 365 and virtualization environments.
• Troubleshoot enterprise networking and infrastructure issues.
• Support GxP-regulated laboratory applications and chromatography data systems.
• Partner with QA and CSV teams on validation, change controls, CAPAs and audits.
• Ensure compliance with cGMP and data integrity requirements.
• Take ownership of technical issues through to resolution and drive infrastructure projects.

Skills

IT infrastructure

Independent senior resource

Regulatory/compliance mindset

Tools

Windows Server

Active Directory

Microsoft 365

Virtualization

Networking

CSV

cGMP

FDA 21 CFR Part 11

Job description

I'm supporting an established organization within the pharmaceutical/life sciences industry looking to add a Lead IT Systems Engineer to their South Florida operation.

This is a hands-on, site-based position and would suit someone with a strong combination of IT infrastructure experience and GxP/regulatory systems knowledge who is comfortable acting as a senior technical resource for a regulated site.

Key areas of responsibility:

• Lead day-to-day IT operations and technical support for the site
• Support Windows Server, Active Directory, Microsoft 365 and virtualization environments
• Troubleshoot enterprise networking and infrastructure issues
• Support GxP-regulated laboratory applications, chromatography data systems and instrument-connected systems
• Partner closely with QA and CSV teams on validation, change controls, CAPAs, deviations and audits
• Ensure compliance with cGMP, FDA 21 CFR Part 11 and data integrity requirements
• Take ownership of technical issues through to resolution and support ongoing infrastructure and systems projects

What we're looking for:

• 5+ years of IT infrastructure / systems support experience
• 2+ years working within a GxP-regulated pharmaceutical, biotech, medical device or similar environment


• Experience supporting laboratory or chromatography data systems strongly preferred
• Strong Windows Server, Active Directory, Microsoft 365 and virtualization knowledge


• Good understanding of enterprise networking
• Experience with CSV, cGMP and FDA 21 CFR Part 11


• Someone comfortable working independently and taking ownership as the senior technical resource on-site

This is an excellent opportunity for an experienced GxP IT professional to take ownership of a broad, business-critical technology environment within an established life sciences organization.