Title: Lab Support
Location: Malvern, Pennsylvania, United States
Catalyx is seeking a Lab Systems MLL Support Specialist provides technical and application support for laboratory IT systems, equipment, and infrastructure within a regulated pharmaceutical and life sciences environment.
Key Responsibilities
- 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 the 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, standard operating procedures (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. Requirements Requirements
- Bachelor's degree in Information Technology, Computer Science, Information Systems, or a related technical discipline, or equivalent practical experience.
- 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 Technical Skills
- Knowledge of Laboratory Information Management Systems (LIMS).
- Familiarity with Electronic Laboratory Notebooks (ELN) and laboratory applications.
- Understanding of Windows operating systems, networking, hardware, and software troubleshooting.
- Experience with laboratory instrument connectivity and integration.
- Familiarity with IT service management, incident management, and ticketing systems.
- Understanding of system validation, change control, and technical documentation. Regulatory Knowledge
- Understanding of GxP and GMP requirements.
- Familiarity with FDA 21 CFR Part 11.
- Knowledge of computer system validation (CSV) and data integrity principles.