Lab Support IT Administrator

Cynet Systems•Wilmington, OH

About The Position

The Lab Support IT Administrator will administer, support, maintain, and troubleshoot Windows-based laboratory workstations and associated infrastructure supporting analytical and manufacturing laboratory instruments. This role involves managing the complete lifecycle of these systems, from provisioning and deployment to upgrades, migrations, validation support, and decommissioning. The administrator will perform advanced hardware and software troubleshooting to minimize laboratory downtime and coordinate system enhancements with various teams and vendors. A key aspect of this role is ensuring laboratory systems operate in compliance with GMP, GLP, GCP, FDA, and other regulatory requirements, including supporting and maintaining validated systems through Computer System Validation (CSV) methodologies. The position also involves authoring and executing validation documentation, supporting regulatory inspections, and ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity Principles, and GAMP 5. The administrator will also perform periodic reviews, analyze system trends, conduct risk assessments, lead investigations, and develop corrective action plans. Additionally, the role includes administering Active Directory environments, designing and maintaining OUs and GPOs, managing permissions, and implementing endpoint protection. Engineering and support for laboratory networks, assessment of third-party software, and translating technical concepts for stakeholders are also key responsibilities. Collaboration with cross-functional teams and external vendors is essential.

Requirements

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.
PowerShell 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.
Strong verbal and written communication skills.
Excellent communication and presentation skills.
Ability to communicate effectively with stakeholders.

Nice To Haves

VMware virtualization technologies.
Waters Empower, ThermoFisher Sample Manager, MODA-EM, or similar laboratory software platforms.

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 workstation hardening.
Manage local workstation permissions, privileged accounts, service accounts, and role-based access controls.
Implement and support endpoint protection technologies including Antivirus and Endpoint Detection and Response (EDR).
Develop and implement compensating controls for unsupported or restricted laboratory systems.
Provide engineering and support for laboratory networks including TCP/IP, DNS, DHCP, VLANs, and Firewall technologies.
Assess third-party laboratory software and vendor applications for alignment with enterprise architecture and regulatory expectations.
Translate complex technical concepts into business-focused language for stakeholders and leadership.
Facilitate cross-functional collaboration between IT, Cybersecurity, Quality Assurance, Validation, Engineering, and external vendors.