Information Systems EngineeringLOCATION: Wilmington, OhioWORK MODEL: On-site • 5 days/weekSCHEDULE: 8-5pm • Monday-FridayTHE OPPORTUNITYAfidence 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 ForEducation: 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 Sample:
Manager, 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 WorkWork 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.
