Lab IT administrator

Location:
Wilmington, OH 45177

Mode :
Contract (6+ Months) - Onsite

Local candidates only

USC/GC only

• Administer, support, maintain, and troubleshoot Windows-based laboratory workstations (Windows 7 through current supported versions) 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 as required which may include:
  • User Requirements Specifications (URS)
  • Functional Requirements Specifications (FRS)
  • Design Specifications
  • Risk Assessments
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Summary Reports
  • 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