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Sr. Lab Systems Support Engineer (GxP/CSV - Pharmaceutical Lab IT)

ICONMA LLC
Rahway, NJ, United States
13 days ago

Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Working hours
Regular working hours
Job source
www.careerjet.com

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

Apply for this position

This job is hosted externally. Click below to view the full posting and apply.

Apply on www.careerjet.com

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