Asset Reliability Engineer

24 hours ago

Raritan, United States Tbwa Chiatday Inc Full time
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ. Role Overview The Asset / Reliability Engineer will be responsible for ensuring equipment/systems required to support an expanding Cell Therapy facility is appropriately purchased, qualified, deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems engineering team. This role will require technical expertise and troubleshooting ability and shall drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients. This individual will be an integral part of the CAR-T Equipment team in support of ongoing clinical and commercial manufacturing as well as facility expansions and improvements. Key Responsibilities Responsible for the technical support of all equipment and process support installations, focusing on preventing failures, increasing availability, and improving EHS & QUALITY compliance. Document proposals to reach solutions with relevant stakeholders (e.g., QA, C&Q, Operations) and develop root cause analyses in the context of Quality Investigations (QI's). Support CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems, and write SOPs (Standard Operating Procedures) and work instructions that are part of the QMS (Quality Management System). Analyze the complete maintenance process using information from maintenance personnel, SAP, and technical documentation to convey outcomes to the Maintenance Manager. Monitor and evaluate the performance of the preventive maintenance plan and adjust as necessary based on changing operating conditions. Lead new projects and provide technical support for improvement projects of other departments, seeking new technologies/devices to optimize processes. Maintain close contact with suppliers of various devices and ensure correct SLA (Service License Agreement) is concluded. Requirements Bachelors Degree Preferably in Engineering or Life Sciences Minimum 3 years of experience in Facility, Engineering, and/or Operations in a GMP production environment Experience in biotechnology or Cell Therapy preferred Experience managing others preferred Experience with managing utility and/or process equipment from specification development through full implementation in a GMP Commercial Facility Experience with Commissioning/Qualification, Asset Change Control, Process/System Improvement, Asset Lifecycle activities/documentation. Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks. Strong organizational skills. Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional requirements and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment. Strong understanding of regulatory and compliance requirements Excellent oral and written communication skills; highly collaborative and inclusive Ability to effectively mentor and coach junior team members J-18808-Ljbffr

by Jobble

  • Facilities Engineer

    3 weeks ago

    Raritan, United States QuidelOrtho Full time

    The OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...

  • Facilities Engineer

    3 weeks ago

    Raritan, United States QuidelOrtho Full time

    The OpportunityQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with...

  • Facility Engineer

    2 days ago

    Raritan, United States Legend Biotech US Full time

    Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

  • Cloud Solutions Engineer

    4 days ago

    Raritan, New Jersey, United States Birlasoft Full time

    Cloud Solutions EngineerWe are seeking a highly skilled Cloud Solutions Engineer to join our team in Raritan, New Jersey. As a key member of our organization, you will be responsible for designing and implementing scalable, secure, and resilient cloud solutions that meet business needs.Key Responsibilities:Design and implement cloud-based solutions across...

  • Associate Software Engineer

    6 days ago

    Raritan, United States UKG Full time

    Company Overview With 80,000 customers across 150 countries, UKG is the largest U.S.-based private software company in the world. And were only getting started. Ready to bring your bold ideas and collaborative mindset to an organization that still has so much more to build and achieve? Read on. At UKG, you get more than just a job. You get to work with...

  • Senior Calibration Specialist

    1 week ago

    Raritan, New Jersey, United States Mastech Digital Full time

    Job OverviewMastech Digital is seeking a highly skilled Senior Calibration Specialist to join our team. In this role, you will be responsible for providing Maximo experience and expertise in the creation of new asset, engineering, calibration data sheet templates, job plans, preventive maintenance, and work order generation in a cGMP manufacturing...

  • Manufacturing Execution Systems Engineer

    1 week ago

    Raritan, United States Legend Biotech US Full time

    Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK)...

  • Solution Architect, Regulatory Strategy

    5 days ago

    Raritan, United States Apptad Inc. Full time

    Job Title: Solution Architect, Regulatory StrategyLocation: Raritan, NJ (Onsite) Duration: Long Term We are seeking an experienced Solution Architect to support Regulatory Strategy projects from the site in Raritan, NJ. The Regulatory Strategy Product Group delivers solutions which drive process orchestration, intelligent automation, advanced analytics and...

  • Data Architect

    1 week ago

    Raritan, United States JobRialto Full time

    Job Summary The Data Architect will be responsible for designing, creating, deploying, and managing the organization's data architecture, ensuring optimal data integration, storage, and analysis capabilities. This role works closely with data engineers and analysts to develop scalable data pipelines and analytical tools that empower decision-making...

  • Solutions Architect

    4 weeks ago

    Raritan, United States Birlasoft Full time

    About Birlasoft:Birlasoft, a powerhouse where domain expertise, enterprise solutions, and digital technologies converge to redefine business processes. We take pride in our consultative and design thinking approach, driving societal progress by enabling our customers to run businesses with unmatched efficiency and innovation. As part of the CK Birla Group, a...

  • Seasonal Warehouse Worker

    4 weeks ago

    Raritan, United States United Parcel Service Full time

    SHIFT YOUR FUTURE Seasonal Warehouse Worker UPS Quick Apply Applying for this role online is quick and easy – and you could even schedule your first day of work within 10 minutes! The steps are simple: 1) Provide some basic information to start the application process. 2) Watch a short video to see what the job is like. 3) Complete our...

  • Data architect: Snowflake, Data Modeling and Migration

    1 week ago

    Raritan, United States APN Consulting Full time

    Direct Client Requirement Job Title: Data Architect - Snowflake, Data Modeling & Migration (Regulatory Pharma) Location: Raritan/Bridgewater/Trenton NJ (Hybrid- once a week) Job Type: Contract Department: Data & Analytics / IT Job Description: We are seeking a highly skilled Data Architect with expertise in Snowflake, data modeling, and data migration,...

  • Driver Helper

    1 month ago

    RARITAN, United States United Parcel Service Full time

    SHIFT YOUR FUTURE Seasonal Driver Helper SHIFT YOUR TEAM Who exactly are UPS Seasonal Driver Helpers? As a Driver Helper this is a position where you’ll ride along with a Package Delivery Driver in our famous brown trucks and help get packages of all shapes and sizes exactly where they need to be. It’s a lot of in and out of the truck, making...

  • Solution Architect

    22 hours ago

    Raritan, NJ, United States StaffEagle LLC Full time

    Job Title: Solution Architect ( with experience - AWS, Azure, GCP , Regulatory) Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck. Location: Raritan, New Jersey (Onsite) Job Duration- Long -Term JD- Must have experience in Regulatory Domain with some exp in VEEVA The Solution...