Lab Support IT admin

Laboratory Systems Administration
* Administer, support, maintain, and troubleshoot Windows-based laboratory workstations (Windows 7 through current supported versions) 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. GxP Compliance, Validation & Data Integrity
* 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 as required which may include:
* User Requirements Specifications (URS)
* Functional Requirements Specifications (FRS)
* Design Specifications
* Risk Assessments
* Installation Qualification (IQ)
* Operational Qualification (OQ)
* Performance Qualification (PQ)
* Validation Summary Reports
* 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
* GAMP 5 methodologies
* Corporate cybersecurity and quality standards Compliance Reporting, Assessments & Quality Systems
* 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
* Security Assessments
* Technical Impact Assessments
* Compliance Status Reports
* Analyze system trends, audit findings, and operational performance data to identify compliance risks and improvement opportunities. Risk Assessment & Root Cause Analysis
* Conduct technical and compliance risk assessments related to infrastructure, laboratory applications, instrument software, cybersecurity vulnerabilities, and system changes.
* Evaluate risks affecting product quality, patient safety, data integrity, system availability, and regulatory compliance.
* 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 Analysis
* Fishbone Analysis
* Root Cause Analysis (RCA)
* Failure Mode and Effects Analysis (FMEA)
* Develop corrective and preventive action plans (CAPAs) to address identified issues and prevent recurrence.
* Document investigation findings, impact assessments, and remediation plans. Identity & Access Management:
* Administer Active Directory environments supporting laboratory and regulated systems.
* Design, implement, and maintain Organizational Units (OUs), security groups, delegated administration models, and authentication services in partnership with the corporate Active Directory team.
* Develop and maintain Group Policy Objects (GPOs) supporting security baselines, workstation hardening, application controls, and laboratory compliance requirements.
* Manage local workstation permissions, privileged accounts, service accounts, and role-based access controls.
* Conduct periodic access reviews to verify appropriate user permissions and segregation of duties.
* Ensure identity and access management processes comply with GxP and data integrity requirements. Cybersecurity & Endpoint Security:
* Execute cybersecurity efforts supporting laboratory workstations and regulated systems.
* Implement and support endpoint protection technologies including:
* Antivirus solutions
* Endpoint Detection and Response (EDR)
* Assess cybersecurity risks associated with legacy operating systems and vendor-supported instrument software.
* Develop and implement compensating controls for unsupported or restricted laboratory systems.
* Support security monitoring, incident response, remediation activities, and vulnerability assessments.
* Collaborate with Information Security teams to maintain secure laboratory environments while preserving validated system states. Networking, Infrastructure & Firewall Technologies:
* Provide engineering and support for laboratory networks and infrastructure.
* Demonstrate advanced knowledge of:
* TCP/IP Networking
* DNS
* DHCP
* VLANs
* Rou