Job Title: Lab Support IT administrator
Location: Wilmington, OH 45177
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.