Senior IT Lab Specialist

Cellares•Bridgewater, NJ

18d•$90,000 - $210,000

About The Position

We are seeking a Senior IT Lab Specialist to oversee IT operations supporting the GMP-regulated laboratory environment. This role ensures that all laboratory computer systems, connected instruments, and supporting infrastructure operate reliably, securely, and in compliance with quality, security, and compliance requirements. The specialist collaborates with Laboratory, Quality, and IT teams to handle equipment setup, qualification, backup and restore procedures, and periodic reviews. Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.

Requirements

Bachelor’s degree in Information Technology, Computer Science, or related field
5-7 years of IT experience in a GMP, GLP, or regulated manufacturing environment
Solid understanding of laboratory instruments and data systems (LIMS, Cellaca devices, PCR etc.)
Experience with Windows-based systems, backup technologies, and network configurations
Familiarity with data integrity standards and GxP documentation practices
Knowledge of cybersecurity controls in regulated environments
Working knowledge of validation lifecycle (CSV) and system risk assessments

Responsibilities

Provide day-to-day IT support for laboratory instruments, applications, and data systems within a GMP Lab environment
Troubleshoot and resolve hardware, software, and connectivity issues on lab equipment (Cell Counters, Flow Cytometers, LIMS, PCR, Microbial detection system, etc.)
Coordinate with instrument and software vendors for maintenance, service requests, and technical escalations
Manage system backups, data integrity checks, and restore testing per company policies and regulatory requirements
Maintain user accounts, access controls, and security permissions following defined procedures and segregation of duties
Act as document owner for IT-related GMP procedures (system administration, backup/restoration, user management, etc.)
Support validation and qualification activities for lab systems (IQ/OQ/PQ) in collaboration with QA and vendors
Ensure compliance with 21 CFR Part 11, EU Annex 11, and internal computer system validation policies
Manage and execute change control activities, including impact assessments, risk evaluations, and approval documentation prior to implementing software patches, configuration changes, or upgrades
Support periodic review of computerized systems, including patching, lifecycle management, and audit trail review
Assist in laboratory system upgrades, migrations, and integrations with enterprise applications (e.g., LIMS, ELN)
Participate in internal and external audits as an SME for laboratory IT systems and infrastructure
Provide training and guidance to lab users on IT procedures, data handling, and security requirements
Provide backup support to cross-functional IT teams to ensure continuity of operations and timely resolution of technical issues across laboratory and business systems