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

Our Client, an IT Services and Consultant company, is looking for a Sr. Lab Systems Support Engineer (GxP/CSV – Pharmaceutical Lab IT) 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

• 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

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities