Laboratory Equipment IT Engineer, Cell Medicines

Laboratory Equipment IT Engineer, Regeneron Cell Medicines

Join to apply for the Laboratory Equipment IT Engineer, Regeneron Cell Medicines role at Regeneron

Laboratory Equipment IT Engineer, Regeneron Cell Medicines

1 week ago Be among the first 25 applicants

Join to apply for the Laboratory Equipment IT Engineer, Regeneron Cell Medicines role at Regeneron

Get AI-powered advice on this job and more exclusive features.

We are seeking a motivated Laboratory Equipment IT Engineer to support and maintain Building Management, Clinical Manufacturing Equipment and data acquisition/monitoring systems that support Clinical Manufacturing and Research and Development (R&D). This role is a part of Regeneron Cell Medicines (RCM), a newly formed R&D unit within Regeneron to advance cell therapies and combination approaches in oncology and immunology. We hope you are excited to serve as the technical SME as well as operate at the system administration, engineering, and management levels.

As an Laboratory Equipment IT Engineer, a typical day might include the following:

• 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

This Role Might Be For You If You

• 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

In order to be considered for this role, you must have at least a 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 very advantageous.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual…