Laboratory Equipment IT Engineer, Regeneron Cell Medicines
- Supporting all manufacturing and QC equipment within RCMs 30,000 SF Phase 1 clinical manufacturing facility
- Maintaining System documentation, including converting User Requirement Specifications to a Detail Design Specification, 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
- Support engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing to meet end user requirements
- Supporting automation activities by updating/authoring system specifications, user and functional requirements specifications, as well as generating and implementing necessary 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 as required to ensure system can meet defined RTO and RPO; perform recovery of data 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 requirement and/or design specifications, test plans, technical evaluation and quality risk assessments
- Supporting system integration with existing systems (ex. LIMS, Historian) as required by business needs
- You enjoy working in a fast-paced environment and can be flexible with changing priorities
- You thrive in a team-based, multi-functional, collaborative environment
- You possess a problem-solving mentality
- You have excellent verbal and written communication skills
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