Validation Engineer

Senior Lab Systems Support EngineerLocation: Rahway, NJ (Onsite) or West Point, PA (Onsite)Job SummarySTAFFXPERT seeking an experienced Senior Lab Systems Support Engineer to support laboratory IT systems within a regulated pharmaceutical environment. The ideal candidate will have extensive experience managing the complete laboratory system lifecycle, supporting analytical instruments, ensuring regulatory compliance, and collaborating with laboratory, QA, IT, and vendors. This role requires strong expertise in Computer System Validation (CSV), GxP compliance, laboratory applications, and pharmaceutical business processes.Required Skills (Must Have)Laboratory System Lifecycle Management Laboratory Systems Vendor Management Pharmaceutical Laboratory Business Processes Computer System Validation (CSV) GxP / GMP / GLP / 21 CFR Part 11 Compliance SDLC and Validation Documentation Laboratory Instrument Integration ServiceNow or Remedy Ticketing Systems CAPA, Change Control, Deviation Management Data Integrity (ALCOA+) Audit Readiness and Regulatory Compliance Required QualificationsBachelor's degree in Computer Science, Information Technology, Life Sciences, Chemistry, Biology, or a related discipline. 8+ years of experience supporting Laboratory IT Systems in a pharmaceutical, biotechnology, or life sciences environment. Strong understanding of regulated laboratory environments. Hands-on experience with Computer System Validation (CSV). Knowledge of laboratory software platforms and analytical instruments. Experience with ServiceNow, Remedy, or similar ITSM platforms. Strong troubleshooting, communication, and documentation skills. Key ResponsibilitiesLaboratory System Lifecycle ManagementManage the complete lifecycle of laboratory systems including implementation, qualification, validation, maintenance, upgrades, patching, backup, archival, restoration, and decommissioning. Ensure compliance with SDLC, CSV, GxP, FDA, and 21 CFR Part 11 regulations. Support validation documentation including IQ, OQ, PQ, URS, FS, DS, RTM, and Validation Summary Reports. Coordinate monthly patching, software deployments, and system upgrades. Laboratory Systems AdministrationAdminister laboratory applications and standalone systems. Perform user account management including provisioning, modification, and deactivation. Configure laboratory systems, access controls, and application settings. Manage backup, disaster recovery, and data archival activities. Maintain system documentation, SOPs, and Work Instructions.