Lab Support IT administrator Wilmington - OH - Ohio

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 backuprecovery activities for laboratory systems.

GxP Compliance, Validation & Data Integrity

* Ensure laboratory systems operate in compliance with GMP, GLP, Google Cloud Platform, 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

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:

* TCPIP Networking

* DNS

* DHCP

* VLANs

* Routing and Switching

* Network Segmentation

* Wireless Technologies

* Firewall Technologies

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

Third-Party Software & Technology Evaluation:

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

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

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

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

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

Technical Communication & Leadership:

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

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

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

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

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

BASIC QUALIFICATIONS:

Minimum Education:

* Bachelors degree in information technology, Computer Science, Engineering, Biotechnology, or a related technical discipline.

* Equivalent combination of education and experience may be considered.

Experience:

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

* 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.

Technical KnowledgeSkills Needed:

Required:

* 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 TCPIP, 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.

Preferred:

* VMware virtualization technologies.

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