Job Description
Information Systems Engineering
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LOCATION: Wilmington, Ohio
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WORK MODEL: On-site • 5 days/week
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SCHEDULE: 8-5pm • Monday-Friday
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THE OPPORTUNITY
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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.
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What You’ll Be Responsible For:
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Laboratory Systems Administration
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- 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.
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GxP Compliance, Validation & Data Integrity
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- 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.
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Compliance Reporting, Assessments & Quality Systems
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- 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.
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Risk Assessment & Root Cause Analysis
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- 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.
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Identity & Access Management
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- 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.
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Cybersecurity & Endpoint Security
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- 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.
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Networking, Infrastructure & Firewall Technologies
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- 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.
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Third-Party Software & Technology Evaluation
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- 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.
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Technical Communication & Leadership
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- 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.
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What We’re Looking For
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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.
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Experience
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- 5+ years of IT infrastructure, systems engineering, or systems administration experience.
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Required Technical Knowledge
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- 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.
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Preferred Experience
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- 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.
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How You’ll Work
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- 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.
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About Afidence
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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.