Lab IT administrator

Manufacturing Pharmacetical laboratory experience
Relevant Minimum Exp 8 to 10
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.

• 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

• 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.

• 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.

• 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.

• 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.

• 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…