GxP IT Systems Specialist — 21 CFR Part 11 Expert

Actalent; United States; Hybrid; USD 69,000 - 103,000; Full time

Job summary

Actalent is seeking a GxP IT Systems Specialist to support a major compliance initiative targeting ~32 legacy GxP systems. The role focuses on Windows systems administration, Active Directory, configuration, data integrity, access controls, and 21 CFR Part 11 compliance.

The candidate will remediate gaps, document configurations, and support qualification activities within a regulated pharmaceutical/biotech/medical device setting.

Qualifications

• 5+ years of IT systems experience.
• 3+ years supporting GxP systems in regulated life sciences.
• Strong Windows Server administration experience.
• Hands-on AD, Group Policy, user access and permissions.
• Familiar with 21 CFR Part 11, GxP, and data integrity requirements.
• Experience with computerized system compliance/validation.
• Backup/restore, server configuration, and app admin.
• Networking and IT security fundamentals.
• Formal change control experience.
• Ability to document configurations and SOPs.

Responsibilities

• Configure and remediate legacy GxP systems to meet compliance.
• Administer Windows Server and Active Directory including GPOs.
• Configure audit trails, time sync, and electronic records protections.
• Establish and support backup, restore, and archiving processes.
• Support 21 CFR Part 11 compliance and data integrity requirements.
• Write and maintain system administration SOPs and docs.
• Develop privilege/access matrices and document configurations.
• Support IQ and verification protocols.
• Capture screenshots and evidence for system qualification.
• Document changes per GxP change control procedures.
• Collaborate with IT teams on access management and downtime.
• Troubleshoot and configure GxP apps and infrastructure.
• Strengthen security and access controls across systems.

Skills

Windows Server

Active Directory

Group Policy

GxP Compliance

21 CFR Part 11

Data Integrity

System Validation

Backup & Restore

Networking Basics

Change Control

Documentation SOPs

Access Management

Tools

VMware

SQL Server

LIMS

CDS

MES

Job description

Actalent is seeking a GxP IT Systems Specialist to support a major compliance initiative targeting ~32 legacy GxP systems. The role focuses on Windows systems administration, Active Directory, configuration, data integrity, access controls, and 21 CFR Part 11 compliance.

The candidate will remediate gaps, document configurations, and support qualification activities within a regulated pharmaceutical/biotech/medical device setting.