LAB Support

Sira Consulting, an Inc 5000 company; Wilmington (OH); On-site; USD 120,000 - 150,000; Full time

Job summary

Sira Consulting, an Inc 5000 company, is seeking an IT infrastructure specialist to support regulatory-compliant laboratory systems and validated environments. You will administer Windows workstations, AD, GPOs, and security controls, while coordinating risk assessments, change controls, and audits.

The role requires hands-on experience with CSV, validation methodologies, and collaboration across IT, QA, and validation teams to ensure product quality and data integrity.

Qualifications

• Bachelor’s degree in IT, CS, engineering, biotech, or related field; equivalent combos may be considered.
• 5+ years IT infrastructure, systems engineering, or systems administration experience.
• 3+ years supporting regulated GxP systems in life sciences.
• Experience with laboratory instrumentation and validated systems.
• Familiarity with FDA and international regulatory requirements.

Responsibilities

• Translate complex technical concepts for laboratory operations, QA, and leadership.
• Present risks, compliance findings, and system health assessments to stakeholders.
• Develop executive summaries, technical reports, and decision-support docs.
• Lead cross-functional collaboration between IT, Validation, Quality, and vendors.
• Support investigations of system failures, deviations, and cybersecurity incidents.

Skills

Windows administration

Active Directory

GPO administration

Privileged access management

Endpoint security

Vulnerability management

Networking fundamentals

PowerShell scripting

Backup and DR

CSV methodologies

Data integrity

Regulatory compliance

Root cause analysis

Audit trail reviews

Documentation and reports

Technical leadership

Education

Bachelor's degree in information technology, Computer Science, Engineering, Biotechnology, or a related technical discipline

Tools

VMware virtualization

Waters Empower

MODA-EM

ThermoFisher Sample Manager

Job description

• 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
• 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.
• 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
• 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:

• 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.