Senior Laboratory Systems Engineer
Engagement: Long-Term Contract with Potential for Conversion
Location: Cincinnati, Ohio | On-Site, Monday–Friday
Position Summary
A life sciences organization in the Cincinnati area is seeking a Senior Laboratory Systems Analyst to provide hands-on technical ownership of computerized systems used within Quality Control and Research & Development laboratories.
This position supports the full lifecycle of regulated laboratory technology—from implementation and validation through daily administration, security, upgrades, troubleshooting, and eventual retirement. The analyst will work closely with laboratory users, Quality, Validation, Cybersecurity, Engineering, infrastructure teams, and technology vendors to maintain reliable, secure, and inspection-ready systems.
The role is well suited for someone who combines strong Windows and infrastructure knowledge with experience supporting validated systems in a GxP-regulated environment.
Primary Responsibilities
Laboratory Technology Operations
- Provide day-to-day administration and technical support for laboratory computers, scientific applications, instrument-connected workstations, and related infrastructure.
- Diagnose and resolve hardware, software, operating system, application, connectivity, and instrument-integration issues.
- Coordinate system installations, upgrades, migrations, patches, configuration changes, and retirement activities.
- Partner with laboratory personnel and external vendors to implement enhancements and minimize operational disruptions.
- Monitor system health and proactively address reliability, performance, security, and supportability concerns.
- Contribute to backup, recovery, disaster-recovery, and business-continuity planning for critical laboratory systems.
Validated Systems and Regulatory Compliance
- Maintain computerized laboratory systems in accordance with applicable GxP requirements and established quality procedures.
- Support Computer System Validation activities throughout the system lifecycle.
- Create, review, or execute documentation such as:
- User and functional requirements
- System and compliance risk assessments
- Installation, operational, and performance qualification protocols
- Test scripts and supporting evidence
- Requirements traceability documentation
- Validation summary reports
- Participate in internal audits, regulatory inspections, periodic system reviews, and quality assessments.
- Help ensure laboratory technology complies with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data-integrity expectations.
- Maintain accurate system records and ensure changes are completed through approved documentation and quality processes.
Access Administration and Cybersecurity
- Support Active Directory services associated with regulated laboratory environments.
- Manage user accounts, security groups, permissions, Group Policy, and role-based access.
- Assist with endpoint protection, operating-system hardening, vulnerability remediation, and security monitoring.
- Evaluate proposed security changes for their potential impact on validated systems and laboratory operations.
- Collaborate with cybersecurity teams during risk reviews, incident investigations, and remediation efforts.
- Help maintain secure and appropriately segmented laboratory environments without compromising system functionality or validated status.
Infrastructure and Connectivity
- Support the network connectivity required by laboratory instruments, applications, workstations, servers, and peripheral devices.
- Troubleshoot TCP/IP, DNS, DHCP, VLAN, routing, switching, firewall, and network-segmentation issues.
- Coordinate with infrastructure and network teams to resolve complex technical problems.
- Assist with virtualized environments, system backups, and recovery processes when applicable.
Quality and Risk Management
- Perform technical, operational, cybersecurity, and compliance risk assessments.
- Investigate recurring system issues and lead or contribute to root-cause analysis.
- Support deviations, change controls, corrective and preventive actions, and continuous-improvement initiatives.
- Prepare system assessments, compliance metrics, technical reports, and leadership-level summaries.
- Identify opportunities to improve system reliability, documentation quality, support processes, and inspection readiness.
- Serve as a technical resource for laboratory users and cross-functional business partners.
Required Qualifications
- Bachelor’s degree in Information Technology, Computer Science, Engineering, Biotechnology, or a related discipline; equivalent professional experience may also be considered.
- At least five years of experience in systems administration, infrastructure support, engineering technology, or IT operations.
- At least three years of experience supporting computerized systems in a pharmaceutical, biotechnology, medical-device, or comparable GxP-regulated environment.
- Hands-on experience supporting laboratory applications, scientific instrumentation, or instrument-connected computing systems.
- Working knowledge of Computer System Validation and regulated system-lifecycle practices.
- Understanding of electronic records, data integrity, audit-trail, access-control, and compliance requirements.
- Ability to independently troubleshoot complex issues and coordinate resolution across multiple technical and business teams.
Core Technical Experience
- Microsoft Windows workstation and server administration
- Active Directory, security groups, permissions, and Group Policy
- PowerShell scripting or task automation
- Endpoint security, vulnerability remediation, and system hardening
- Backup, restoration, and disaster-recovery practices
- Computer System Validation documentation and execution
- FDA 21 CFR Part 11 and GxP compliance
- Risk assessment, change control, CAPA, and root-cause analysis
- TCP/IP, DNS, DHCP, VLANs, routing, and switching
- Firewalls and network-segmentation concepts
Preferred Experience
- Experience supporting chromatography data systems, laboratory information management systems, electronic lab-execution platforms, or similar scientific applications.
- Familiarity with platforms such as Empower, SampleManager, MODA, or comparable laboratory technologies.
- Experience working with VMware or another virtualization platform.
- Exposure to Operational Technology or manufacturing-connected systems.
- Familiarity with ISA/IEC 62443 or similar industrial cybersecurity frameworks.
- Microsoft, ITIL, or other relevant technical certifications.
Ideal Candidate Profile
The successful candidate will be comfortable working directly with both technology and laboratory teams. They will understand that changes to regulated systems require careful planning, documentation, testing, and cross-functional approval.
This individual should be able to balance system availability, cybersecurity, compliance, and business needs while communicating clearly with technical professionals, scientists, quality personnel, vendors, and organizational leaders. Strong ownership, sound judgment, attention to detail, and the ability to work with limited supervision are essential.