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.
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