Lab IT Administrator

Position: Lab Support IT Administrator
Job Overview:
Pay Range: $28.00hr - $33.00hr Requirement/Must Have:
Bachelor's degree in information technology, Computer Science, Engineering, Biotechnology, or a related technical discipline. 6+ years of experience in IT infrastructure, systems engineering, or systems administration. 3+ years supporting regulated GxP systems within pharmaceutical, biotechnology, medical device, or life sciences organizations. Experience supporting laboratory instrumentation and computerized systems validation. Experience working within highly regulated environments subject to FDA and international regulatory requirements.

Microsoft Windows administration (Windows 7 through current supported versions). Advanced Active Directory administration. Expert-level Group Policy Object (GPO) administration and troubleshooting. Local permissions and privileged access management. Endpoint security technologies and cybersecurity controls. Vulnerability management and system hardening. Networking technologies including TCP/IP, DNS, DHCP, VLANs, routing, and switching. Firewall technologies and network segmentation. Power Shell scripting and automation. Backup, disaster recovery, and business continuity processes.

Risk assessment and root cause analysis methodologies. Audit trail review and user access review processes. Computerized System Validation (CSV) methodologies. Data Integrity principles and regulatory compliance frameworks. Responsibilities:
Administer, support, maintain, and troubleshoot Windows-based laboratory workstations and associated infrastructure supporting analytical and manufacturing laboratory instruments. Install, configure, upgrade, patch, and maintain operating systems, instrument software, middleware, and supporting applications. Manage complete lifecycle activities including provisioning, imaging, deployment, upgrades, migrations, validation support, and decommissioning. Perform advanced hardware and software troubleshooting for instrument-attached workstations while minimizing laboratory downtime. Coordinate upgrades, migrations, software releases, and system enhancements with laboratory personnel, validation teams, and equipment vendors.

Support business continuity, disaster recovery, and backup/recovery activities for laboratory systems. Ensure laboratory systems operate in compliance with GMP, GLP, GCP, FDA, and other applicable regulatory requirements. Support and maintain validated systems through established Computer System Validation (CSV) methodologies. Author, review, and execute validation documentation including URS, FRS, Design Specifications, Risk Assessments, IQ, OQ, PQ, Validation Summary Reports, and Traceability Matrices.

Maintain systems in a validated state through approved change control processes. Support regulatory inspections, customer audits, quality audits, and compliance assessments. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity Principles, and GAMP 5 methodologies. Perform and document periodic reviews and assessments of GxP systems to ensure ongoing compliance and operational effectiveness. Generate and maintain Periodic System Reviews, Data Integrity Assessments, User Access Reviews, Audit Trail Reviews, and Security Assessments.

Analyze system trends, audit findings, and operational performance data to identify compliance risks and improvement opportunities. Conduct technical and compliance risk assessments related to infrastructure, laboratory applications, instrument software, and cybersecurity vulnerabilities. Lead investigations involving system failures, deviations, cybersecurity incidents, and compliance concerns. Perform fault isolation, troubleshooting, and root cause analysis utilizing methodologies such as 5 Why, Fishbone, RCA, and FMEA.

Develop corrective and preventive action plans (CAPAs) to address identified issues and prevent recurrence. Administer Active Directory environments supporting laboratory and regulated systems. Design, implement, and maintain Organizational Units (OUs), security groups, and delegated administration models. Develop and maintain Group Policy Objects (GPOs) supporting security baselines and…