Sr. Lab Systems Support Engineer (GxP/CSV - Pharmaceutical Lab IT)
ICONMA LLC
Rahway, United States of America
2 days ago
Role details
Contract type
Permanent contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
English Experience level
SeniorJob location
Rahway, United States of America
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