Computer System Validation Jobs in Ohio (NOW HIRING)

• Bachelor’s degree in information technology, Computer Science, Engineering, Biotechnology, or a related technical discipline.
• 6+ years of experience in IT infrastructure, systems engineering, or systems administration.
• 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.
• 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.

• Administer, support, maintain, and troubleshoot Windows-based laboratory workstations 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.
• 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.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, ALCOA+ Data Integrity Principles, and GAMP 5 methodologies.
• 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, and Security Assessments.
• 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, and cybersecurity vulnerabilities.
• 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, Fishbone, RCA, and FMEA.
• Develop corrective and preventive action plans (CAPAs) to address identified issues and prevent recurrence.
• Administer Active Directory environments supporting laboratory and regulated systems.
• Design, implement, and maintain Organizational Units (OUs), security groups, and delegated administration models.
• Develop and maintain Group Policy Objects (GPOs) supporting security baselines and workstation hardening.
• Manage local workstation permissions, privileged accounts, service accounts, and role-based access controls.
• Implement and support endpoint protection technologies including Antivirus and Endpoint Detection and Response (EDR).
• Develop and implement compensating controls for unsupported or restricted laboratory systems.
• Provide engineering and support for laboratory networks including TCP/IP, DNS, DHCP, VLANs, and Firewall technologies.
• Assess third-party laboratory software and vendor applications for alignment with enterprise architecture and regulatory expectations.
• Translate complex technical concepts into business-focused language for stakeholders and leadership.
• Facilitate cross-functional collaboration between IT, Cybersecurity, Quality Assurance, Validation, Engineering, and external vendors.

• VMware virtualization technologies.
• Waters Empower, ThermoFisher Sample Manager, MODA-EM, or similar laboratory software platforms.

• Lab Support.
• GxP.
• Windows troubleshooting.
• Active Directory.
• Group Policy Objects (GPO).
• Computerized System Validation (CSV).
• Data Integrity.
• Cybersecurity.
• Networking.
• PowerShell.
• Root Cause Analysis.
• Risk Assessment.

• Bachelor’s degree in information technology, Computer Science, Engineering, Biotechnology, or a related technical discipline.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.
• Ability to communicate effectively with stakeholders.

Benefits:

Our Benefits Include:

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities

Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.