W2 Role: GxP System administrator

About the Role

Administer, support, maintain, and troubleshoot Windows-based laboratory workstations (Windows 7 through current supported versions) and associated infrastructure supporting analytical and manufacturing laboratory instruments. Ensure compliance with GxP, validation, data integrity, and cybersecurity standards while minimizing laboratory downtime.

Responsibilities

• Install, configure, upgrade, patch, and maintain operating systems, instrument software, middleware, and supporting applications for laboratory workstations.
• 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.
• 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, including:
  • 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, and corporate cybersecurity and quality standards.
• Perform and document periodic reviews and assessments of GxP systems to ensure ongoing compliance and operational effectiveness, including:
  • 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.
• 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 using 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.
• Administer Active Directory environments supporting laboratory and regulated systems, including:
  • Designing and maintaining Organizational Units (OUs), security groups, and delegated administration models.
  • Developing and maintaining Group Policy Objects (GPOs) for security baselines, workstation hardening, and compliance.
• 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.
• Execute cybersecurity efforts for laboratory workstations and regulated systems, including:
  • Implementing antivirus solutions and Endpoint Detection and Response (EDR).
  • Assessing cybersecurity risks associated with legacy systems and vendor-supported software.
  • Developing compensating controls for unsupported or restricted laboratory systems.
  • Supporting security monitoring, incident response, remediation, and vulnerability assessments.
• Provide engineering and support for laboratory networks and infrastructure, including:
  • TCP/IP Networking, DNS, DHCP, VLANs, routing, switching, and network segmentation.
  • Wireless and firewall technologies.
  • Troubleshooting network connectivity for laboratory instruments, workstations, servers, and integrated systems.
• Assess third-party laboratory software, vendor applications, and supporting technologies for alignment with enterprise architecture, cybersecurity, 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.
• Translate complex technical concepts into business-focused language for non-technical stakeholders.
• Present technical risks, compliance findings, system health assessments, and strategic recommendations.
• 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.

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.
• 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.

Skills

• Microsoft Windows administration (Windows 7 through current supported versions).
• Advanced Active Directory administration and Group Policy Object (GPO) 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, switching, and firewall technologies.
• PowerShell scripting and automation.
• Backup, disaster recovery, and business continuity processes.
• Risk assessment and root cause analysis methodologies (e.g., 5 Why, Fishbone, RCA, FMEA).
• Audit trail review and user access review processes.
• Computerized System Validation (CSV) methodologies and data integrity principles.
• Regulatory compliance frameworks (e.g., FDA 21 CFR Part 11, EU Annex 11, ALCOA+, GAMP 5).
• Preferred: VMware virtualization technologies.
• Preferred: Experience with laboratory software platforms such as Waters Empower, ThermoFisher Sample Manager, or MODA-EM.