Senior Lab Systems Support Engineer
Staffxpert Llc
Rahway, United States of America
7 days ago
Role details
Contract type
Temporary to permanent Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
English Experience level
SeniorJob location
Rahway, United States of America
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
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.