Lab Support IT administrator

Position: Lab Support IT administrator

Location: Wilmington, OH 45177***Onsite***

Duration: 1 Years

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
  • 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:

• Bachelor's 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 Knowledge/Skills 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 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.

Preferred:

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