Laboratory Equipment IT Engineer, Regeneron Cell Medicines

Role Summary

Laboratory Equipment IT Engineer role supporting and maintaining Building Management, Clinical Manufacturing Equipment and data acquisition/monitoring systems for Clinical Manufacturing and R&D within Regeneron Cell Medicines (RCM).

Responsibilities

• Supporting all manufacturing and QC equipment within RCM’s Phase 1 clinical manufacturing facility
• Maintaining system documentation, including converting User Requirement Specifications to Detail Design Specifications, writing Configuration Test Plans, and summary reports
• Leading IT applications systems security access and periodic audit trail reviews
• Performing investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software
• Supporting engineering and validation projects and providing support to manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing
• Supporting automation activities by updating/authoring system specifications, user and functional requirements specifications, and generating/implementing FAT and SAT protocols
• Designing and developing test plans and implementing software/hardware improvements to automated process control and process monitoring equipment according to change control procedures
• Ensuring systems' data is backed up/archived to meet defined RTO and RPO; perform data recovery as needed
• Creating and maintaining configuration specifications for cGMP software for process control, monitoring and testing
• Ensuring systems remain in compliant state including process change control requests for system configurations, including requirements/design specifications, test plans, technical evaluation and quality risk assessments
• Supporting system integration with existing systems (e.g., LIMS, Historian) as required by business needs

Qualifications

• Required: Bachelor's degree in Information Technology or related field
• Required: 3-5 years of relevant experience in a manufacturing/lab/IT setting
• Required: Experience in a pharmaceutical or biopharmaceutical manufacturing facility
• Required: Experience with automated systems for environmental monitoring and compliance; Rees is preferred
• Preferred: Experience working in a GMP environment

Skills

• Strong problem-solving abilities and excellent verbal and written communication
• Ability to operate as a technical SME at system administration, engineering, and management levels
• Experience with system documentation, specifications, and change control
• Familiarity with integration to systems like LIMS and Historian

Education

• Bachelor's degree in Information Technology or related field