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
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
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What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
