Senior Systems Engineer
ICONMA
Senior Lab Systems Support Engineer (GxP/CSV – Pharmaceutical Lab IT)Our client, an IT Services and Consultant company, is looking for a Senior Lab Systems Support Engineer for their Rahway, NJ location. Responsibilities include:Lab System Lifecycle Management:Manage end to end lab system lifecycle including implementation validation maintenance and decommissioningEnsure compliance with SDLC CSV GxP and regulatory standardsHandle system upgrades patching backup archival and audit readinessLab System Vendor Handling:Act as point of contact for vendors for installation support and issue resolutionCoordinate maintenance upgrades and ensure SLA and regulatory complianceManage vendor deliverables documentation and escalation handlingLab 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 standardsCollaborate with QA IT and lab teams to support audits and process improvementsProvide 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 teamVendor communications coordination during the System Hardware failures & any other MaintenancesBackup of the Standalone and Benchtop systems on regular basisApplication Software upgrades on the standalone systems.Onboarding and off boarding Lab systemsMonthly patching coordination.Backup & Restoration for the Lab systemsLac/es ConfigurationUpdate SOPs/ WIsAssist 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 include: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.12.00 Years of ExperienceWhy Should You Apply?Health BenefitsReferral ProgramExcellent growth and advancement opportunities
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