Sr. Systems Analyst, Information Systems Engineering

Gravity IT Resources; Cincinnati (OH); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Gravity IT Resources in Cincinnati, OH seeks a Senior Systems Analyst to support regulated laboratory computing systems. You will administer Windows workstations, manage validation, and ensure GMP/GxP compliance while aligning IT with Quality and R&D needs.

You will collaborate with lab personnel, validation specialists, cybersecurity teams, and external vendors to maintain secure, audit-ready systems, participate in risk assessments, and support change controls and CAPA processes.

Qualifications

• Bachelor’s degree or equivalent experience in IT/CS/Engineering or related field.
• 5+ years of experience in systems administration, infrastructure engineering, or IT operations.
• 3+ years supporting regulated GxP systems in pharmaceutical, biotechnology, medical device, or life sciences environments.
• Experience supporting laboratory systems, scientific applications, or laboratory instrumentation.
• Knowledge of Computer System Validation (CSV) principles and regulated environments.
• Strong understanding of data integrity and compliance requirements.

Responsabilités

• Administer, maintain, and troubleshoot Windows-based laboratory workstations and supporting infrastructure.
• Support laboratory instruments, instrument software, and associated applications.
• Manage system lifecycle activities including deployment, upgrades, migrations, patching, validation support, and decommissioning.
• Minimize downtime through proactive support and problem resolution.
• Collaborate with laboratory teams and vendors on system upgrades and enhancements.
• Support backup, disaster recovery, and business continuity initiatives.

Connaissances

Windows administration

Active Directory administration

Group Policy Management

PowerShell scripting

Endpoint security

Backup and disaster recovery

Computer System Validation (CSV)

FDA 21 CFR Part 11 compliance

Networking basics

Cybersecurity collaboration

Formation

Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field

Outils

Empower

SampleManager

MODA

VMware

Description du poste

Job Title: Senior Systems Analyst, Information Systems Engineering
Job Type: Long Term Contract | Contract to Hire
Location:Cincinnati, OH; On-site | Monday-Friday, First Shift
Industry: Pharmaceutical / Life Sciences

Overview

We are seeking an experienced Senior Systems Analyst to support critical laboratory systems within a regulated pharmaceutical environment. This role is responsible for the administration, security, validation, compliance, and lifecycle management of laboratory computing systems that support Quality Control and Research & Development operations.

The ideal candidate brings a combination of technical expertise, regulatory knowledge, and a passion for solving complex challenges within highly regulated environments. You will work closely with laboratory personnel, quality teams, validation specialists, cybersecurity professionals, engineers, and external vendors to ensure laboratory systems remain secure, compliant, reliable, and inspection-ready.

This is an excellent opportunity for a hands-on IT professional who enjoys working at the intersection of technology, science, compliance, and innovation.

What You’ll Do

Laboratory Systems Support

• Administer, maintain, and troubleshoot Windows-based laboratory workstations and supporting infrastructure.
• Support laboratory instruments, instrument software, and associated applications.
• Manage system lifecycle activities including deployment, upgrades, migrations, patching, validation support, and decommissioning.
• Minimize downtime through proactive support and problem resolution.
• Collaborate with laboratory teams and vendors on system upgrades and enhancements.
• Support backup, disaster recovery, and business continuity initiatives.

Compliance & Validation

• Maintain systems in compliance with GMP, GLP, GCP, FDA, and other applicable regulatory requirements.
• Support validated systems through established Computer System Validation (CSV) processes.
• Participate in development and execution of validation documentation, including:
  • Requirements Specifications
  • Risk Assessments
  • IQ/OQ/PQ Protocols
  • Validation Reports
  • Traceability Documentation
• Support audits, inspections, and quality assessments.
• Ensure compliance with:
  • FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • ALCOA+ Data Integrity Principles

Cybersecurity & Identity Management

• Manage Active Directory environments supporting regulated systems.
• Administer security groups, user access, permissions, and Group Policy.
• Support endpoint protection, vulnerability management, and workstation hardening.
• Partner with cybersecurity teams on risk mitigation, monitoring, and incident response activities.
• Help maintain secure laboratory environments while preserving validation and compliance requirements.

Infrastructure & Networking

• Support laboratory network infrastructure and connectivity.
• Troubleshoot issues involving:
  • TCP/IP
  • DNS
  • DHCP
  • VLANs
  • Routing and Switching
  • Firewall Technologies
  • Network Segmentation

Risk Management & Continuous Improvement

• Conduct technical and compliance risk assessments.
• Lead root cause investigations and support corrective/preventive actions (CAPA).
• Participate in change control, deviation investigations, and quality improvement initiatives.
• Generate compliance reports, system assessments, and executive-level summaries.
• Serve as a trusted technical advisor to laboratory and business stakeholders.

Qualifications

Required

• Bachelor’s degree in Information Technology, Computer Science, Engineering, Biotechnology, or a related field, or equivalent experience.
• 5+ years of experience in systems administration, infrastructure engineering, or IT operations.
• 3+ years supporting regulated GxP systems in pharmaceutical, biotechnology, medical device, or life sciences environments.
• Experience supporting laboratory systems, scientific applications, or laboratory instrumentation.
• Knowledge of Computer System Validation (CSV) principles and regulated environments.
• Strong understanding of data integrity and compliance requirements.

Technical Skills

• Microsoft Windows administration
• Active Directory administration
• Group Policy Management (GPO)
• Endpoint security and system hardening
• PowerShell scripting
• Backup and disaster recovery processes
• Computer System Validation (CSV)
• FDA 21 CFR Part 11 compliance
• Risk assessment and root cause analysis
• Networking fundamentals (TCP/IP, DNS, DHCP, VLANs)
• Firewall technologies and network security

Preferred

• Experience with laboratory platforms such as Empower, SampleManager, MODA, or similar systems.
• VMware experience.
• Experience supporting Operational Technology (OT) environments.
• Familiarity with ISA/IEC 62443 cybersecurity standards.
• Microsoft or ITIL certifications.

What Success Looks Like

You are someone who:

• Thrives in highly regulated environments.
• Enjoys solving complex technical challenges.
• Can balance compliance, cybersecurity, and operational needs.
• Builds strong partnerships across IT, Quality, Validation, and Laboratory teams.
• Communicates technical concepts clearly to both technical and non-technical audiences.
• Takes ownership and works effectively with minimal supervision.

Equal Employment Opportunity Statement
Gravity IT Resources is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, veteran status, or any other legally protected characteristic. All employment decisions are based on qualifications, merit, and business needs.