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
· 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
· 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.
