Laboratory Equipment IT Engineer, Regeneron Cell Medicines
Regeneron
Full-time
Remote friendly (Cambridge, MA)
United States
IT
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Role Summary
Laboratory Equipment IT Engineer at Regeneron Cell Medicines. Support and maintain Building Management, Clinical Manufacturing Equipment and data acquisition/monitoring systems that support Clinical Manufacturing and R&D. Serve as technical SME and operate at system administration, engineering, and management levels.
Responsibilities
- Supporting all manufacturing and QC equipment within RCM’s 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
Qualifications
- Required: Bachelor’s degree in Information Technology or related field and 3–5 years of relevant experience in a manufacturing/lab/IT setting
- Must have experience in a pharmaceutical or biopharmaceutical manufacturing facility
- Must have experience with automated systems for environmental monitoring and compliance; Rees is preferred
- Experience working in a GMP environment is advantageous
Skills
- Strong problem-solving and analytical skills
- Excellent verbal and written communication skills
- Ability to work in fast-paced, changing priorities environments
- Team-based, multi-functional collaboration
Education
- Bachelor’s degree in Information Technology or related field
Additional Requirements
- None specified