Staff Engineer - CAR-T Industrial IT Systems

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Engineer - CAR-T Industrial IT Systems!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at https://www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today. To support the global CAR-T program, Janssen is rapidly growing its manufacturing and laboratory capabilities. This position offers a perfect environment to understand CAR-T Cell Processing Manufacturing Operations and the underlying Asset & Building Management systems, something unique given the limited amount of Cell Therapy manufacturers worldwide. Apply today for this exciting chance to be part of the #CAR-T team!

Our Raritan, NJ Cell Therapy facility is scaling up operational flows to serve more patients and meet the highest quality standards without compromising manufacturing efficiency. This exciting new role works with the CAR-T Engineering & Technical Services Lead and will tasked with providing technical expertise, using best practices, and developing internal as well as external partnerships around our ISA-95 Level 1 and 2 (manufacturing) automated systems and applicable interfaces supporting manufacturing operations onsite.

The Staff Engineer is responsible for ensuring that automated systems are fit for intended use and follow applicable regulatory requirements and company manufacturing standards throughout the entire system life cycle. They will also ensure flawless liaison with the different teams, vendors, sites, and stakeholders. The Engineer serves as a specialist in the field of industrial automation through their extensive experience of systems and platforms. They have accountability for maintaining and enhancing these systems as well as identifying and driving opportunities for continuous improvement across the systems and platforms.

Key Responsibilities:

• Maintain and be responsible for the industrial IT systems (https://e.g., BMS, EMS, IDP (Instrument Data Platform), OSI PI, etc.) in compliance with its procedures, work instructions, and all applicable regulatory GxP and corporate requirements.
• Ensure reliable availability of systems, including the containing data.
• Triage system issues to find root cause and propose a solution (potentially 24/7 on-call support is required).
• Configure and manage system interfaces, user administration, conduct system performance monitoring, and implement & maintain network configuration (in partnership with IT).
• Provide training to end users and system administrators.
• Lead and supervise modifications/projects implementation and create & maintain lifecycle documentation.
• Responsible for software update for process and laboratory equipment platforms and integration with manufacturing systems (https://e.g., MES, eLIMS, etc.).
• Ensure user requirement specifications and all applicable objectives are met to maintain the platform daily (including backup, disaster recovery, user administration etc.).
• Lead vendors, subcontractors, and/or technical integrators.
• Review, develop, and execute (commissioning) protocols, test plans, reports, and documentation to implement, maintain, operate, and validate GxP automated systems.
• Drive innovation and new technologies.
• Support investigations, deviations, and corrective & preventive actions towards successful compliance and timely closure.
• Actively communicate regularly with Operations and project delivery stakeholders.