Senior System Analyst

Information Systems Engineering

LOCATION: Wilmington, Ohio

WORK MODEL: On-site - 5 days/week

SCHEDULE: 8-5pm - Monday-Friday

THE OPPORTUNITY

Afidence is seeking an experienced Senior Systems Analyst to support a highly regulated laboratory environment in Wilmington, Ohio. This role functions as a senior IT administrator/engineer for GxP laboratory systems, with responsibility spanning Windows-based laboratory workstations, validation and compliance, cybersecurity, identity and access management, networking, and technology lifecycle management. The consultant will serve as a key technical partner across IT, Quality, Validation, Engineering, Laboratory Operations, Cybersecurity, and third-party vendors to help keep regulated systems secure, available, compliant, and inspection-ready.

What You’ll Be Responsible For:

Laboratory Systems Administration

• Administer, support, maintain, and troubleshoot Windows-based laboratory workstations (Windows 7 through current supported versions) and supporting infrastructure for analytical and manufacturing laboratory instruments.
• Install, configure, upgrade, patch, and maintain operating systems, instrument software, middleware, and supporting applications.
• Manage full system 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, including URS, FRS, design specifications, risk assessments, IQ/OQ/PQ, validation summary reports, and traceability matrices.
• Maintain systems in a validated state through approved change-control processes.
• Support regulatory inspections, customer audits, quality audits, and compliance assessments.
• Work within FDA 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, GAMP 5 methodologies, and applicable corporate cybersecurity and quality standards.

Compliance Reporting, Assessments & Quality Systems

• Perform and document periodic reviews and assessments of GxP systems to confirm 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, and compliance status reports.
• Analyze system trends, audit findings, and operational performance data to identify compliance risks and improvement opportunities.
• Support deviation investigations, quality events, change controls, and CAPA activities.
• Prepare technical documentation and executive summaries for quality management reviews and regulatory inspections.

Risk Assessment & Root Cause Analysis

• Conduct technical and compliance risk assessments involving 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 and root cause analysis using methods such as 5 Why, Fishbone Analysis, RCA, and FMEA.
• Develop corrective and preventive action plans (CAPAs), and document investigation findings, impact assessments, and remediation plans.

Identity & Access Management

• Administer Active Directory environments supporting laboratory and regulated systems.
• Design, implement, and maintain OUs, security groups, delegated administration models, and authentication services in partnership with enterprise Active Directory teams.
• Develop and maintain Group Policy Objects (GPOs) for 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 and ensure identity/access processes align with GxP and data integrity requirements.

Cybersecurity & Endpoint Security

• Execute cybersecurity activities supporting laboratory workstations and regulated systems.
• Implement and support endpoint security technologies including antivirus and Endpoint Detection and Response (EDR).
• Assess risks associated with legacy operating systems and vendor-supported instrument software, and implement compensating controls where required.
• 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.
• Apply advanced knowledge of TCP/IP, DNS, DHCP, VLANs, routing and switching, network segmentation, wireless technologies, and firewall technologies.
• Troubleshoot 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 and develop recommendations for implementation, remediation, and lifecycle planning.
• Partner with vendors and internal stakeholders to align solutions with organizational standards and industry best practices.

Technical Communication & Leadership

• Translate complex technical concepts into practical, 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 and facilitate cross-functional collaboration across IT, Cybersecurity, Quality Assurance, Validation, Engineering, Operations, and external vendors.

What We’re Looking For

Education: Bachelor’s degree in Information Technology, Computer Science, Engineering, Biotechnology, or a related technical discipline;
an equivalent combination of education and experience may be considered.

Experience

• 5+ years of IT infrastructure, systems engineering, or systems administration experience.

Required Technical Knowledge

• Microsoft Windows administration (Windows 7 through current supported versions).
• Advanced Active Directory administration and expert-level Group Policy Object (GPO) administration/troubleshooting.
• Local permissions, privileged access management, endpoint security, cybersecurity controls, vulnerability management, and system hardening.
• Networking technologies including TCP/IP, DNS, DHCP, VLANs, routing, switching, firewalls, and network segmentation.
• PowerShell scripting and automation.
• Backup, disaster recovery, and business continuity processes.
• Risk assessment, root cause analysis, audit trail review, and user access review processes.
• Computerized System Validation (CSV), data integrity principles, and regulatory compliance frameworks.

Preferred Experience

• 3+ years supporting regulated GxP systems within pharmaceutical, biotechnology, medical device, or life sciences organizations.
• Hands-on experience supporting laboratory instrumentation and computerized systems validation.
• Experience working in highly regulated environments subject to FDA and international regulatory requirements.
• Previous experience working in GxP laboratories and qualifying new laboratory systems to 21 CFR Part 11 requirements.
• VMware or Hyper-V virtualization technologies.
• Waters Empower, Thermo Fisher SampleManager, MODA-EM, or similar laboratory software platforms.
• Knowledge of ISA/IEC 62443 industrial cybersecurity standards.
• ITIL and/or Microsoft certifications.
• Experience supporting Operational Technology (OT) environments.

How You’ll Work

• Work autonomously while collaborating closely with technical, quality, validation, laboratory, cybersecurity, and vendor stakeholders.
• Adapt to shifting priorities and approach new issues with curiosity, critical thinking, and strong problem-solving skills.
• Communicate technical information clearly to both technical and non-technical audiences.
• Use risk-based judgment, strong attention to detail, and a quality-focused mindset to support regulated operations.
• Take a customer-focused approach to supporting laboratory operations and regulated business functions.

About Afidence

Afidence is a technology consulting firm that helps organizations bring clarity to complex technology decisions and move important initiatives forward. We pair experienced consultants with a relationship-first approach across infrastructure, cybersecurity, application development, data, and AI. Our consultants are expected to communicate clearly, solve problems thoughtfully, and build trust with the teams they support.