It Specialist

GxP IT Systems SpecialistPosition 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 job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time 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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr Actalent