Senior Principal Cell Processing Robotics Engineer

Job Title : Senior Principal Cell Processing Robotics Engineer

Johnson & Johnson Innovative Medicines, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Principal Cell Processing Robotics Engineer. This Hybrid position can be based in Titusville, New Jersey, Springhouse, PA, or Raritan, New Jersey.

CAR-T is an innovative treatment, which uses the power of the patient's own immune system. A patient's T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results. JJIM is working to develop, manufacture, and commercialize products in the CAR-T space. The CAR-T Engineering organization provides ownership and oversight for the entire asset portfolio and associated business processes for JJIM's Advanced Therapies Supply Chain. Along the lifecycle of our assets, such as facilities, equipment, and utilities, this role is the key point of contact for technical matters related to cell processing mechatronics systems.

The CAR-T Robotics Engineer is responsible for providing technical expertise, using best practices, and developing internal as well as external partnerships within the CAR-T program at the site level and beyond. They will be a key contributor to ensure flawless execution during project design, qualification, startup and transition to operations and asset replacement projects, and will closely collaborate with the different project organizations, vendors, sites, and partners. In addition, the Engineer will create and sustain continuous technical improvements around our asset base and supports problem solving as needed. Daily, the Engineer partners with R&D, Operations, MSAT, Quality, and 3rd party partners, as well as Environment Health & Safety.

The Senior Principal CAR-T Robotics Engineer will act as a decision maker in the Engineering workstream and partner with R&D, E&PS, Operations and Quality to ensure facility and equipment design meet operational requirements. You will manage and drive engineering systems through Engineering, Procurement, and Construction Phases to ensure on-time system delivery. As technical owner of cell processing mechatronics systems, the Engineer is responsible for qualified system turnover to the end user. You will collaborate in the development and own set-up of supply chain technology and processes for the design of a next-generation manufacturing facility.

This role provides process engineering ownership of the robotically controlled process steps and processes for the CAR-T cell processing commercial facility project. The project will highly automate an autologous Cell Therapy process using, in large part, disposable technology biotherapy manual processes performed or supplemented by robotics. Robotics processes will include material movement, disposable bioreactor manipulations, tube manipulations and welding, adding / removing materials from workstations, passthroughs, and cryopreservation units.

The process is performed in grade C cleanroom space and will be fully GMP compliant. This role will serve as the Subject Matter Expert (SME) for the robotics, robotics controls, and interfaces between robotically controlled motions and human operators.

Key Responsibilities :

• As CAR-T Cell Processing Mechatronics / Robotics System Owner, represent Engineering in Facility & Equipment Design, Qualification and Startup, through transfer to the end user. Support tech transfer activities through process validation and regulatory approval.
• Create or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, and operational documents. Ensure business requirements are incorporated into the design; responsible for business owner approval of requirement specifications.
• Ownership and SME for Mechatronics / Robotics equipment and technology secure relationships with equipment and technology partners to ensure smooth transition from project custody. Provide technical support to Engineering / MAM, Design, Automation, Construction Management, CQV / Start-up, Operations, and EHS teams as required the project.
• Work with project team to assure robotics deliverables are within project timelines and budget.
• Coordinate the selection and oversight of third-party engineering and design services through authoring and initiating formal RFP documentation for competitive bidding and then execution of objective and data driven analysis documented in bid analysis forms.
• In partnership with E&PS lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility.
• Participate as Mechatronics / Robotics SME and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.).
• Assure compliance with relevant safety standards for human and robotics interactions. Provide guidance to team on most current ANSI / RIA R15.06, ISO 10218-1, ISO 13849, site and corporate specifications, and state and federal regulations.
• Support development of integrated process data map and criticality assessments for use in automation and manufacturing systems deliverables.
• Accountable for cost and resources within system(s) of responsibility.
• Develop asset management procedures, PM, maintenance and calibration.
• Drive the standards for the asset portfolio and provide asset ownership as a service for production / laboratory equipment, facilities, and clean / GMP utilities.
• Accompany all stages of a typical asset lifecycle, including replacement planning & vendor evaluation / selection.
• Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure.
• Participate in compliance inspections / audits within area of responsibility.
• Ensure compliance with all applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies and corporate standards.
• Actively communicate regularly with the Engineering community and foster expertise sharing with CAR-T entities around the globe.
• Analyze processes to find opportunities for optimization, efficiency improvements, and cost savings. Furthermore, a portion of your time will be focused on developing detailed knowledge of CAR-T production processes :
• Develop & maintain in-depth understanding of the CAR-T manufacturing processes (including sound scientific understanding), operational procedures and manufacturing environment (Facilities, Utilities, Equipment, Systems, Processes)
• Develop & maintain robust understanding of aseptic and cell processing techniques.
• Develop & maintain an in-depth knowledge of cell processing robotics and automation.
• Develop & maintain understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)

Qualifications : Education :

Experience and Skills :