GxP IT Systems Specialist - Hybrid (Onsite First Month)

Actalent; Miami (FL); Hybrid; USD 69,000 - 103,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO

Job summary

Actalent is seeking a GxP IT Systems Specialist to support a major compliance initiative involving ~32 legacy GxP systems. The role focuses on Windows administration, Active Directory, 21 CFR Part 11 compliance, data integrity, and change control in a regulated life sciences environment.

You will remediate compliance gaps, document configurations, and support IQ/validation activities across IT, quality, and business stakeholders.

Qualifications

• 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.

Responsibilities

• 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

Skills

GxP Systems

Windows Server

Active Directory

Group Policy

21 CFR Part 11

Data Integrity

Audit Trails

Change Control

IQ

Backup & Restore

VMware

SQL Server

LIMS

CDS

MES

SOPs

System Validation

Documentation

Tools

VMware

SQL Server

LIMS

CDS

MES

Job description

Actalent is seeking a GxP IT Systems Specialist to support a major compliance initiative involving ~32 legacy GxP systems. The role focuses on Windows administration, Active Directory, 21 CFR Part 11 compliance, data integrity, and change control in a regulated life sciences environment.

You will remediate compliance gaps, document configurations, and support IQ/validation activities across IT, quality, and business stakeholders.