Sr. Lab Systems Support Engineer (GxP/CSV - Pharmaceutical Lab IT)
ICONMA LLC
Rahway, NJ, United States
about 2 months ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Working hours
Regular working hours
Job source
Tech stack
Data Integrity
Issue Tracking Systems
Systems Development Life Cycle
Software Systems
System Testing
GXP
Servicenow
Job description
- Lab System Lifecycle Management:
- Manage end to end lab system lifecycle including implementation validation maintenance and decommissioning
- Ensure compliance with SDLC CSV GxP and regulatory standards
- Handle system upgrades patching backup archival and audit readiness
- Lab System Vendor Handling:
- Act as point of contact for vendors for installation support and issue resolution
- Coordinate maintenance upgrades and ensure SLA and regulatory compliance
- Manage vendor deliverables documentation and escalation handling
- Lab System Business Process Understanding in Pharmaceutical Regulatory Environment. Understand lab workflows and align systems with business and regulatory requirements. Ensure compliance with GLP GMP GxP and data integrity standards
- Collaborate with QA IT and lab teams to support audits and process improvements
Requirements
- Good Knowledge and understanding on the GXP.
- Good knowledge of Computer System Validation.
- Good understanding of laboratory instruments and analytical techniques.
- Familiarity with lab software systems.
- Strong problem-solving and communication skills.
- Ability to work in a regulated environment and follow SOPs.
- Good Knowledge of Ticketing systems (ServiceNow/Remedy etc)
- Good Knowledge on the Problem/Deviation/Change/CAPA Management Process
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