Responsibilities: Lab System Lifecycle Management: Manage end to end lab system lifecycle including implementation validation maintenance and decommissioning. Our Client, an IT Services and Consultant company, is looking for a Senior Lab Systems Support Engineer (GxP/CSV - Pharmaceutical Lab IT) for their Rahway, NJ location.
Numbers & Facts
Location
Rahway, NJ
Description
Our Client, an IT Services and Consultant company, is looking for a Senior 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
Provide first-level hands & feet support for laboratory software systems and instrument integration platforms.
Oversee daily lab activities including scheduling, equipment maintenance, and workflow optimization.
Act as a liaison between the lab and external entities (e.g., regulatory bodies, partner institutions).
User Management Activities (E.g: User Creation, Modification & Deletions etc.)
Hardware related PC/Network - Coordination with Desktop support team
Vendor communications, coordination during the System Hardware failures & any other Maintenances
Backup of the Standalone and Benchtop systems on regular basis
Application Software upgrades on the standalone systems.
Onboarding and off boarding Lab systems
Monthly patching coordination.
Backup & Restoration for the Lab systems
Lac/es Configuration
Update SOPs/ WIs
Assist in troubleshooting software and hardware issues related to lab instruments (e.g., HPLC, GC, spectrophotometers).
Ensure accurate documentation of system configurations, user guides, and troubleshooting procedures.
Help maintain audit trails and support data archival processes.
Support compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA regulations.
Ensure systems are validated and maintained according to SOPs and validation protocols.
Work closely with lab analysts, QA, and IT teams to resolve system-related issues.
Participate in cross-functional meetings to improve lab workflows and system performance.
Support Audits Queries from the LAB IT side.
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.
Bachelor's degree in Life Sciences, Chemistry, Biology, Computer Science, or related field.
8+ years of experience in a laboratory or IT support role.