Lab Support IT administrator

Job Description

Laboratory Systems Administration

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• Administer, support, maintain, and troubleshoot Windows-based laboratory workstations (Windows 7 through current supported versions) and associated infrastructure supporting analytical and manufacturing laboratory instruments.

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• Install, configure, upgrade, patch, and maintain operating systems, instrument software, middleware, and supporting applications.

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• Manage complete lifecycle activities including provisioning, imaging, deployment, upgrades, migrations, validation support, and decommissioning.

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• Perform advanced hardware and software troubleshooting for instrument-attached workstations while minimizing laboratory downtime.

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• Coordinate upgrades, migrations, software releases, and system enhancements with laboratory personnel, validation teams, and equipment vendors.

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• Support business continuity, disaster recovery, and backup/recovery activities for laboratory systems.

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GxP Compliance, Validation & Data Integrity

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• Ensure laboratory systems operate in compliance with GMP, GLP, GCP, FDA, and other applicable regulatory requirements.

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• Support and maintain validated systems through established Computer System Validation (CSV) methodologies.

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• Author, review, and execute validation documentation as required which may include:

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• User Requirements Specifications (URS)

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• Functional Requirements Specifications (FRS)

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• Design Specifications

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• Risk Assessments

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• Installation Qualification (IQ)

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• Operational Qualification (OQ)

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• Performance Qualification (PQ)

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• Validation Summary Reports

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• Traceability Matrices

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• Maintain systems in a validated state through approved change control processes.

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• Support regulatory inspections, customer audits, quality audits, and compliance assessments.

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• Ensure compliance with:

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• FDA 21 CFR Part 11

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• EU Annex 11

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• ALCOA+ Data Integrity Principles

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• GAMP 5 methodologies

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• Corporate cybersecurity and quality standards

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Compliance Reporting, Assessments & Quality Systems

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• Perform and document periodic reviews and assessments of GxP systems to ensure ongoing compliance and operational effectiveness.

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• Generate and maintain:

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• Periodic System Reviews

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• Data Integrity Assessments

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• User Access Reviews

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• Audit Trail Reviews

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• Security Assessments

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• Technical Impact Assessments

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• Compliance Status Reports

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• Analyze system trends, audit findings, and operational performance data to identify compliance risks and improvement opportunities.

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Risk Assessment & Root Cause Analysis

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• Conduct technical and compliance risk assessments related to infrastructure, laboratory applications, instrument software, cybersecurity vulnerabilities, and system changes.

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• Evaluate risks affecting product quality, patient safety, data integrity, system availability, and regulatory compliance.

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• Lead investigations involving system failures, deviations, cybersecurity incidents, and compliance concerns.

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• Perform fault isolation, troubleshooting, and root cause analysis utilizing methodologies such as:

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• 5 Why Analysis

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• Fishbone Analysis

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• Root Cause Analysis (RCA)

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• Failure Mode and Effects Analysis (FMEA)

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• Develop corrective and preventive action plans (CAPAs) to address identified issues and prevent recurrence.

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• Document investigation findings, impact assessments, and remediation plans.

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Identity & Access Management:

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• Administer Active Directory environments supporting laboratory and regulated systems.

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• Design, implement, and maintain Organizational Units (OUs), security groups, delegated administration models, and authentication services in partnership with the corporate Active Directory team.

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• Develop and maintain Group Policy Objects (GPOs) supporting security baselines, workstation hardening, application controls, and laboratory compliance requirements.

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• Manage local workstation permissions, privileged accounts, service accounts, and role-based access controls.

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• Conduct periodic access reviews to verify appropriate user permissions and segregation of duties.

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• Ensure identity and access management processes comply with GxP and data integrity requirements.

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Cybersecurity & Endpoint Security:

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• Execute cybersecurity efforts supporting laboratory workstations and regulated systems.

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• Implement and support endpoint protection technologies including:

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• Antivirus solutions

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• Endpoint Detection and Response (EDR)

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• Assess cybersecurity risks associated with legacy operating systems and vendor-supported instrument software.

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• Develop and implement compensating controls for unsupported or restricted laboratory systems.

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• Support security monitoring, incident response, remediation activities, and vulnerability assessments.

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• Collaborate with Information Security teams to maintain secure laboratory environments while preserving validated system states.

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Networking, Infrastructure & Firewall Technologies:

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• Provide engineering and support for laboratory networks and infrastructure.

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• Demonstrate advanced knowledge of:

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• TCP/IP Networking

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• DNS

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• DHCP

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• VLANs

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• Routing and Switching

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• Network Segmentation

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• Wireless Technologies

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• Firewall Technologies

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• Support the troubleshooting network connectivity supporting laboratory instruments, workstations, servers, and integrated business systems.

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Third-Party Software & Technology Evaluation:

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• Assess third-party laboratory software, vendor applications, and supporting technologies for alignment with enterprise architecture, cybersecurity requirements, and regulatory expectations.

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• Evaluate technical specifications, software requirements, system architecture, and integration capabilities.

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• Identify security, compliance, operational, and supportability risks associated with proposed solutions.

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• Develop recommendations for software implementation, remediation, and lifecycle planning.

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• Partner with vendors and internal stakeholders to ensure compliance with corporate standards and industry best practices.

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Technical Communication & Leadership:

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• Translate complex technical concepts into business-focused language for laboratory personnel, quality organizations, managers, and executive leadership.

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• Present technical risks, compliance findings, system health assessments, and strategic recommendations to non-technical stakeholders.

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• Develop executive summaries, technical reports, assessment findings, and decision-support documentation.

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• Serve as a trusted technical advisor for laboratory operations, validation, quality, and business leadership.

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• Facilitate cross-functional collaboration between IT, Cybersecurity, Quality Assurance, Validation, Engineering, Operations, and external vendors.

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BASIC QUALIFICATIONS:

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Minimum Education:

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• Bachelor’s degree in information technology, Computer Science, Engineering, Biotechnology, or a related technical discipline.

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• Equivalent combination of education and experience may be considered.

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Experience:

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• 5+ years of IT infrastructure, systems engineering, or systems administration experience.

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• 3+ years supporting regulated GxP systems within pharmaceutical, biotechnology, medical device, or life sciences organizations.

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• Experience supporting laboratory instrumentation and computerized systems validation.

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• Experience working within highly regulated environments subject to FDA and international regulatory requirements.

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Technical Knowledge/Skills Needed:

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Required:

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• Microsoft Windows administration (Windows 7 through current supported versions).

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• Advanced Active Directory administration.

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• Expert-level Group Policy Object (GPO) administration and troubleshooting.

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• Local permissions and privileged access management.

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• Endpoint security technologies and cybersecurity controls.

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• Vulnerability management and system hardening.

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• Networking technologies including TCP/IP, DNS, DHCP, VLANs, routing, and switching.

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• Firewall technologies and network segmentation.

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• PowerShell scripting and automation.

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• Backup, disaster recovery, and business continuity processes.

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• Risk assessment and root cause analysis methodologies.

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• Audit trail review and user access review processes.

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• Computerized System Validation (CSV) methodologies.

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• Data Integrity principles and regulatory compliance frameworks.

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Preferred:

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• VMware virtualization technologies.

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• Waters Empower, ThermoFisher Sample Manager, MODA-EM, or similar laboratory software platforms.

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