It Specialist

GxP IT Systems Specialist

Position Overview

We are seeking an experienced GxP IT Systems Specialist to support a major compliance initiative involving approximately 32 legacy GxP systems. This is a hands-on technical role focused on Windows systems administration, Active Directory, system configuration, data integrity, access controls, and 21 CFR Part 11 compliance.

You will take ownership of remediating identified compliance gaps, documenting system configurations, and supporting qualification activities within a regulated pharmaceutical, biotechnology, or medical device environment.

What Youll Do

+ Configure and remediate legacy GxP computerized systems to meet compliance requirements

+ Administer Windows Server and Active Directory, including users, roles, permissions, password policies, and Group Policy

+ Configure audit trails, session controls, time synchronization, and electronic record protections

+ Establish and support backup, restore, and archiving processes

+ Support compliance with 21 CFR Part 11 and data integrity requirements

+ Write and maintain system administration SOPs and technical documentation

+ Develop privilege/access matrices and document system configurations

+ Support Installation Qualification (IQ) and verification protocols

+ Capture screenshots and technical evidence required for system qualification

+ Document system and configuration changes according to GxP change control procedures

+ Partner with internal IT teams on access management, security, system downtime, and infrastructure changes

+ Support troubleshooting and configuration of GxP applications and supporting infrastructure

+ Help strengthen security and access controls across regulated systems

What Were Looking For

+ 5+ years of IT systems experience

+ At least 3 years supporting GxP systems within pharmaceutical, biotechnology, medical device, or another regulated life sciences environment

+ Strong Windows Server administration experience

+ Hands-on experience with Active Directory, Group Policy, user access, and permissions

+ Working knowledge of 21 CFR Part 11, GxP, and data integrity requirements

+

Experience with computerized system compliance/validation within a regulated environment

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Experience with backup and restore, server configuration, and application administration

+ Understanding of networking and IT security fundamentals

+ Experience working within formal change control processes

+ Ability to create clear technical documentation, configuration records, and SOPs

Preferred Experience

+ Experience supporting LIMS, chromatography data systems (CDS), MES, laboratory systems, or manufacturing applications

+

Experience with VMware or other virtualization platforms

+ Working knowledge of SQL Server

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Experience with audit trails, electronic records, access controls, and security for GxP applications

+ Microsoft, CompTIA, or similar technical certifications are a plus

Work Environment

+ Position will be onsite for approximately the first month to support system assessments, configuration, and documentation

+ Opportunity to transition to a remote arrangement once the initial onsite work is completed and the project reaches a stable phase

+ Project-driven environment with occasional weeks exceeding 40 hours to meet compliance milestones

+ Opportunity to take significant ownership of a defined GxP remediation project and work across IT, quality, and business stakeholders

Key Skills

GxP | 21 CFR Part 11 | Windows Server | Active Directory | Group Policy | GxP Systems | Computer System Validation | Data Integrity | Audit Trails | Access Management | Change Control | IQ | Backup & Restore | VMware | SQL Server | LIMS | CDS | MES | SOPs

Job Type & Location

This is a Contract position based out of Miami, FL.

Pay and Benefits

The…