Johnson & Johnson Innovative Medicine
Senior Principal Cell Processing Robotics Engineer
Johnson & Johnson Innovative Medicine, Raritan, New Jersey, us, 08869
Senior Principal Cell Processing Robotics Engineer
Senior Principal Cell Processing Robotics Engineer
role at
Johnson & Johnson Innovative Medicine
– Hybrid position. Based in Titusville, New Jersey; Spring House, Pennsylvania; or Raritan, New Jersey. Job Description
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, NJ, Spring House, PA, or Raritan, NJ. CAR-T is an innovative treatment that uses the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. 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. The role is the key point of contact for technical matters related to cell processing mechatronics systems, supporting design, qualification, startup, and transition to operations and asset replacement projects. The engineer will collaborate with R&D, Operations, MSAT, Quality, and 3rd party partners to sustain continuous technical improvements and problem solving. They will act as a decision maker in the Engineering workstream and manage engineering systems through Engineering, Procurement, and Construction phases to ensure on-time system delivery, and own qualified system turnover to end users. This role provides process engineering ownership of robotically controlled steps for the CAR-T cell processing commercial facility project. The project will automate an autologous cell therapy process using robotics and disposable technology; robotic processes will include material movement, bioreactor manipulations, tube manipulations and welding, adding/removing materials from workstations, passthroughs, and cryopreservation units. The work occurs in a grade C cleanroom and will be fully GMP compliant. The role serves as the Subject Matter Expert (SME) for robotics, robotics controls, and interfaces between robot 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 ensure 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 own decisions in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.). Assure compliance with safety standards for human and robotics interactions. Provide guidance on ANSI/RIA R15.06, ISO 10218-1, ISO 13849, site and corporate specifications, and applicable regulations. Support development of integrated process data map and criticality assessments for automation and manufacturing systems deliverables. Accountable for cost and resources within the system(s) of responsibility. Develop asset management procedures, PM, maintenance and calibration. Drive standards for the asset portfolio and provide asset ownership as a service for production/lab equipment, facilities, and clean/GMP utilities. Cover all stages of asset lifecycle, including replacement planning and vendor evaluation/selection. Support investigations, deviations, CAPAs toward 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. Communicate regularly with the Engineering community and share expertise with CAR-T entities globally. Analyze processes to identify opportunities for optimization, efficiency improvements, and cost savings. Further responsibilities include developing in-depth knowledge of CAR-T production processes, aseptic and cell processing techniques, and cell processing robotics and automation; maintain understanding of GMP and ATMP regulatory frameworks. Qualifications
Education: Minimum of a Bachelor’s Degree in Mechanical or Electrical Engineering required; focused degree in Mechatronics, Advanced Manufacturing, or Automated Systems preferred. Experience and Skills (Required): Minimum 8 years of relevant work experience. Experience in Manufacturing Operations and/or Engineering environment. Experience with manufacturing process automation and robotics. Proficiency in CAD software; understanding of robotics and automation. Proficiency in programming languages: C++, Python, and/or MATLAB. Familiarity with control systems, signal processing, and PLCs. Experience with equipment/systems commissioning/qualification/validation, Process Automation, IT manufacturing systems. Experience within Pharmaceuticals/Biopharmaceuticals/Large Molecule or equivalent industry; cell therapy (CAR-T) experience is an asset. Hands-on asset ownership experience (equipment, facilities, utilities). Experience managing change, vendor management, change control, and asset replacement strategies. In-depth knowledge of GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (ISO, EN, ICH, FDA, ISPE). Ability to prioritize and manage workload with shifting deadlines; strong collaboration across teams. Service mindset and cross-functional collaboration; capable of hands-on engineering and asset ownership while following procedures. Ability to work independently and manage multiple tasks in a dynamic environment. Preferred: Experience with Staubli robotics technology. Experience with Robot Operating Systems (ROS). Experience with Artificial Intelligence (AI). Experience with Internet of Things (IoT). Other: Requires up to 50% domestic and/or international travel. The anticipated base pay range for this position is $120,000 to $207,000. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you require accommodation during the application process, please contact us via the Johnson & Johnson careers site.
#J-18808-Ljbffr
Senior Principal Cell Processing Robotics Engineer
role at
Johnson & Johnson Innovative Medicine
– Hybrid position. Based in Titusville, New Jersey; Spring House, Pennsylvania; or Raritan, New Jersey. Job Description
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, NJ, Spring House, PA, or Raritan, NJ. CAR-T is an innovative treatment that uses the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. 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. The role is the key point of contact for technical matters related to cell processing mechatronics systems, supporting design, qualification, startup, and transition to operations and asset replacement projects. The engineer will collaborate with R&D, Operations, MSAT, Quality, and 3rd party partners to sustain continuous technical improvements and problem solving. They will act as a decision maker in the Engineering workstream and manage engineering systems through Engineering, Procurement, and Construction phases to ensure on-time system delivery, and own qualified system turnover to end users. This role provides process engineering ownership of robotically controlled steps for the CAR-T cell processing commercial facility project. The project will automate an autologous cell therapy process using robotics and disposable technology; robotic processes will include material movement, bioreactor manipulations, tube manipulations and welding, adding/removing materials from workstations, passthroughs, and cryopreservation units. The work occurs in a grade C cleanroom and will be fully GMP compliant. The role serves as the Subject Matter Expert (SME) for robotics, robotics controls, and interfaces between robot 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 ensure 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 own decisions in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.). Assure compliance with safety standards for human and robotics interactions. Provide guidance on ANSI/RIA R15.06, ISO 10218-1, ISO 13849, site and corporate specifications, and applicable regulations. Support development of integrated process data map and criticality assessments for automation and manufacturing systems deliverables. Accountable for cost and resources within the system(s) of responsibility. Develop asset management procedures, PM, maintenance and calibration. Drive standards for the asset portfolio and provide asset ownership as a service for production/lab equipment, facilities, and clean/GMP utilities. Cover all stages of asset lifecycle, including replacement planning and vendor evaluation/selection. Support investigations, deviations, CAPAs toward 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. Communicate regularly with the Engineering community and share expertise with CAR-T entities globally. Analyze processes to identify opportunities for optimization, efficiency improvements, and cost savings. Further responsibilities include developing in-depth knowledge of CAR-T production processes, aseptic and cell processing techniques, and cell processing robotics and automation; maintain understanding of GMP and ATMP regulatory frameworks. Qualifications
Education: Minimum of a Bachelor’s Degree in Mechanical or Electrical Engineering required; focused degree in Mechatronics, Advanced Manufacturing, or Automated Systems preferred. Experience and Skills (Required): Minimum 8 years of relevant work experience. Experience in Manufacturing Operations and/or Engineering environment. Experience with manufacturing process automation and robotics. Proficiency in CAD software; understanding of robotics and automation. Proficiency in programming languages: C++, Python, and/or MATLAB. Familiarity with control systems, signal processing, and PLCs. Experience with equipment/systems commissioning/qualification/validation, Process Automation, IT manufacturing systems. Experience within Pharmaceuticals/Biopharmaceuticals/Large Molecule or equivalent industry; cell therapy (CAR-T) experience is an asset. Hands-on asset ownership experience (equipment, facilities, utilities). Experience managing change, vendor management, change control, and asset replacement strategies. In-depth knowledge of GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (ISO, EN, ICH, FDA, ISPE). Ability to prioritize and manage workload with shifting deadlines; strong collaboration across teams. Service mindset and cross-functional collaboration; capable of hands-on engineering and asset ownership while following procedures. Ability to work independently and manage multiple tasks in a dynamic environment. Preferred: Experience with Staubli robotics technology. Experience with Robot Operating Systems (ROS). Experience with Artificial Intelligence (AI). Experience with Internet of Things (IoT). Other: Requires up to 50% domestic and/or international travel. The anticipated base pay range for this position is $120,000 to $207,000. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you require accommodation during the application process, please contact us via the Johnson & Johnson careers site.
#J-18808-Ljbffr