Senior Lab Systems Support Engineer

Staffxpert Llc
Rahway, NJ, United States
3 months ago
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Role details

Contract type
Temporary to permanent
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
8 years minimum
Working hours
Regular working hours

Tech stack

Artificial Intelligence Algorithmic Trading Software Documentation Data Integrity Disaster Recovery Issue Tracking Systems Systems Development Life Cycle Software Deployment System Testing Software Troubleshooting Information Technology GXP
+2 more
User Administration Servicenow

Job description

STAFFXPERT seeking an experienced Senior Lab Systems Support Engineer to support laboratory IT systems within a regulated pharmaceutical environment. The ideal candidate will have extensive experience managing the complete laboratory system lifecycle, supporting analytical instruments, ensuring regulatory compliance, and collaborating with laboratory, QA, IT, and vendors. This role requires strong expertise in Computer System Validation (CSV), GxP compliance, laboratory applications, and pharmaceutical business processes., Laboratory System Lifecycle Management

  • Manage the complete lifecycle of laboratory systems including implementation, qualification, validation, maintenance, upgrades, patching, backup, archival, restoration, and decommissioning.
  • Ensure compliance with SDLC, CSV, GxP, FDA, and 21 CFR Part 11 regulations.
  • Support validation documentation including IQ, OQ, PQ, URS, FS, DS, RTM, and Validation Summary Reports.
  • Coordinate monthly patching, software deployments, and system upgrades.

Laboratory Systems Administration

  • Administer laboratory applications and standalone systems.
  • Perform user account management including provisioning, modification, and deactivation.
  • Configure laboratory systems, access controls, and application settings.
  • Manage backup, disaster recovery, and data archival activities.
  • Maintain system documentation, SOPs, and Work Instructions.

Requirements

  • Laboratory System Lifecycle Management
  • Laboratory Systems Vendor Management
  • Pharmaceutical Laboratory Business Processes
  • Computer System Validation (CSV)
  • GxP / GMP / GLP / 21 CFR Part 11 Compliance
  • SDLC and Validation Documentation
  • Laboratory Instrument Integration
  • ServiceNow or Remedy Ticketing Systems
  • CAPA, Change Control, Deviation Management
  • Data Integrity (ALCOA+)
  • Audit Readiness and Regulatory Compliance, * Bachelor’s degree in Computer Science, Information Technology, Life Sciences, Chemistry, Biology, or a related discipline.
  • 8+ years of experience supporting Laboratory IT Systems in a pharmaceutical, biotechnology, or life sciences environment.
  • Strong understanding of regulated laboratory environments.
  • Hands-on experience with Computer System Validation (CSV).
  • Knowledge of laboratory software platforms and analytical instruments.
  • Experience with ServiceNow, Remedy, or similar ITSM platforms.
  • Strong troubleshooting, communication, and documentation skills.

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