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 (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.

• Years of Experience: 12.00 Years of Experience

Why Should You Apply?

• Health Benefits

• Referral Program

• Excellent growth and advancement opportunities