Lab IT Systems Specialist (GxP/GMP)

Catalyx; Pennsylvania; Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

Catalyx is seeking a Lab Systems MLL Support Specialist to provide IT and application support for laboratory IT systems, equipment, and infrastructure in a regulated pharmaceutical/life sciences setting.

You will troubleshoot hardware, software, network, and application issues, support LIMS/ELN and other lab applications, and assist with installation, configuration, and validation activities while ensuring compliance with GxP, GMP, and 21 CFR Part 11.

Qualifications

• Bachelor's degree in Information Technology, Computer Science, Information Systems, or related technical discipline.
• Experience providing IT, application, or technical support in pharmaceutical, biotechnology, medical device, or life sciences environments.
• Experience supporting laboratory systems, scientific applications, or laboratory equipment is highly desirable.
• Experience working in a regulated GxP/GMP environment is preferred.

Responsabilités

• Provide day-to-day IT and technical support for laboratory systems, applications, and equipment.
• Troubleshoot hardware, software, network, and application-related issues within laboratory environments.
• Support Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), and other laboratory applications.
• Assist with installation, configuration, maintenance, and connectivity of laboratory instruments and equipment.
• Provide technical support to laboratory scientists, QC analysts, technicians, and manufacturing personnel.
• Manage incidents, service requests, and problem resolution through IT service management tools.
• Work with IT infrastructure, application teams, vendors, and laboratory stakeholders to resolve technical issues.
• Maintain system documentation, SOPs, and technical records.
• Support system upgrades, changes, testing, and validation activities.
• Ensure laboratory systems operate in compliance with GxP, GMP, and 21 CFR Part 11 requirements.
• Participate in audits, system reviews, and continuous improvement initiatives.

Connaissances

IT support

GxP/GMP knowledge

Technical communication

Formation

Bachelor's degree in IT/CS/Information Systems or related

Outils

LIMS

ELN

Windows OS

ITSM / ticketing systems

Description du poste

Catalyx is seeking a Lab Systems MLL Support Specialist to provide IT and application support for laboratory IT systems, equipment, and infrastructure in a regulated pharmaceutical/life sciences setting.

You will troubleshoot hardware, software, network, and application issues, support LIMS/ELN and other lab applications, and assist with installation, configuration, and validation activities while ensuring compliance with GxP, GMP, and 21 CFR Part 11.