Sr Lab System Support Engineer - W2 Only

Job Description/ Responsibilities

• 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.
• 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.
• 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.

Key Skills & Expertise

• 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.

Job Duties

• Provide first-level hands-on 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 Assistance.
• Support 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.