Our Client, an IT Services and Consultant company, is looking for a Senior Lab System Support Engineer for their Rahway, NJ location.
Responsibilities:
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.