It Specialist

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

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
• 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
• 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 pay range for this position is $50.00 - $75.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

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

Application Deadline

This position is anticipated to close on Nov 6, 2026.

Workplace Type

This is a hybrid position in Miami,FL.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.