Johnson & Johnson Innovative Medicine
Senior Principal QC Labs Robotics Engineer
Johnson & Johnson Innovative Medicine, Titusville, New Jersey, us, 08560
Overview
Senior Principal QC Labs Robotics Engineer – Hybrid position based in Titusville, New Jersey; Spring House, Pennsylvania; or Raritan, New Jersey. This role provides ownership and oversight for the CAR-T Engineering portfolio and associated business processes for JJIM’s Advanced Therapies Supply Chain. The engineer acts as the technical owner of QC Labs mechatronics systems, delivering expertise, best practices, and partnerships within the CAR-T program at the site level and beyond. The role supports project design, qualification, startup, transition to operations, asset replacement projects, and ongoing improvements across the asset base. Daily collaboration occurs with R&D, Operations, MSAT, Quality, EHS, and 3rd party partners." Key Responsibilities
As CAR-T QC Labs 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 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. 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 formal RFP documentation for competitive bidding and data-driven bid analysis. Engage with vendor for FAT/SAT within system of responsibility; participate as Mechatronics / Robotics SME and own safety review decisions (EHS by Design, HAZOPs, machine safety, ergonomics, etc.). Ensure compliance with safety standards for human and robotics interactions; advise on ANSI/RIA R15.06, ISO 10218-1, ISO 13849, site and corporate specs, and relevant regulatory requirements. Support development of integrated process data maps and criticality assessments for automation and manufacturing deliverables. Own cost and resource management within assigned systems; participate in system installations, walkdowns, C&Q and turnover activities during facility construction. Develop asset management procedures, preventive maintenance, and calibration programs; drive standards for the asset portfolio and provide asset ownership services for production/lab equipment, facilities, and utilities; support asset lifecycle including replacement planning and vendor evaluation. Help resolve technical issues quickly; support investigations, deviations, CAPAs, and timely, compliant closure; participate in compliance inspections/audits. Ensure compliance with applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WIs, and company policies; communicate regularly with the broader Engineering community and CAR-T teams globally. Analyze processes to identify optimization opportunities, efficiency improvements, and cost savings. CAR-T Process Knowledge Focus
Develop and maintain in-depth understanding of CAR-T manufacturing processes, including aseptic and cell processing techniques, and robotics/automation in cell processing. Develop understanding of regulatory frameworks (GMP focus, ATMP). Qualifications
Education: Minimum of a Bachelor’s Degree in Mechanical or Electrical Engineering required; a focused degree in Mechatronics, Advanced Manufacturing, or Automated Systems preferred. Experience and Skills: Minimum 8 years of relevant work experience. Experience in Manufacturing Operations, Laboratory Operations and/or Engineering environment. Experience with manufacturing and/or laboratory process automation and robotics. Proficiency in CAD software and understanding of robotics and automation. Proficiency in programming languages: C++, Python, and/or MATLAB. Familiarity with control systems, architecture, signal processing, and PLCs. Experience with equipment/systems commissioning/qualification/validation, Process Automation, IT manufacturing systems. Experience in Pharmaceuticals, Biopharmaceuticals/Large Molecule, or cell therapy (CAR-T) environments. Hands-on asset ownership experience (equipment, facilities, utilities). Experience managing change including vendor management, change control, and asset replacement strategies. In-depth knowledge of current GMP standards and related commissioning/qualification guidelines (ISO, EN, ICH, FDA, ISPE). Ability to prioritize, manage shifting deadlines, and collaborate cross-functionally; proactive problem-solving mindset. Strong communication, independent work style, and ability to lead in a matrix environment. Preferred
Experience with Staubli robotics technology; Robot Operating Systems (ROS); Artificial Intelligence (AI); Internet of Things (IoT). Other
Requires up to 50% domestic and/or international travel. Compensation
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 are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers.
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Senior Principal QC Labs Robotics Engineer – Hybrid position based in Titusville, New Jersey; Spring House, Pennsylvania; or Raritan, New Jersey. This role provides ownership and oversight for the CAR-T Engineering portfolio and associated business processes for JJIM’s Advanced Therapies Supply Chain. The engineer acts as the technical owner of QC Labs mechatronics systems, delivering expertise, best practices, and partnerships within the CAR-T program at the site level and beyond. The role supports project design, qualification, startup, transition to operations, asset replacement projects, and ongoing improvements across the asset base. Daily collaboration occurs with R&D, Operations, MSAT, Quality, EHS, and 3rd party partners." Key Responsibilities
As CAR-T QC Labs 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 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. 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 formal RFP documentation for competitive bidding and data-driven bid analysis. Engage with vendor for FAT/SAT within system of responsibility; participate as Mechatronics / Robotics SME and own safety review decisions (EHS by Design, HAZOPs, machine safety, ergonomics, etc.). Ensure compliance with safety standards for human and robotics interactions; advise on ANSI/RIA R15.06, ISO 10218-1, ISO 13849, site and corporate specs, and relevant regulatory requirements. Support development of integrated process data maps and criticality assessments for automation and manufacturing deliverables. Own cost and resource management within assigned systems; participate in system installations, walkdowns, C&Q and turnover activities during facility construction. Develop asset management procedures, preventive maintenance, and calibration programs; drive standards for the asset portfolio and provide asset ownership services for production/lab equipment, facilities, and utilities; support asset lifecycle including replacement planning and vendor evaluation. Help resolve technical issues quickly; support investigations, deviations, CAPAs, and timely, compliant closure; participate in compliance inspections/audits. Ensure compliance with applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WIs, and company policies; communicate regularly with the broader Engineering community and CAR-T teams globally. Analyze processes to identify optimization opportunities, efficiency improvements, and cost savings. CAR-T Process Knowledge Focus
Develop and maintain in-depth understanding of CAR-T manufacturing processes, including aseptic and cell processing techniques, and robotics/automation in cell processing. Develop understanding of regulatory frameworks (GMP focus, ATMP). Qualifications
Education: Minimum of a Bachelor’s Degree in Mechanical or Electrical Engineering required; a focused degree in Mechatronics, Advanced Manufacturing, or Automated Systems preferred. Experience and Skills: Minimum 8 years of relevant work experience. Experience in Manufacturing Operations, Laboratory Operations and/or Engineering environment. Experience with manufacturing and/or laboratory process automation and robotics. Proficiency in CAD software and understanding of robotics and automation. Proficiency in programming languages: C++, Python, and/or MATLAB. Familiarity with control systems, architecture, signal processing, and PLCs. Experience with equipment/systems commissioning/qualification/validation, Process Automation, IT manufacturing systems. Experience in Pharmaceuticals, Biopharmaceuticals/Large Molecule, or cell therapy (CAR-T) environments. Hands-on asset ownership experience (equipment, facilities, utilities). Experience managing change including vendor management, change control, and asset replacement strategies. In-depth knowledge of current GMP standards and related commissioning/qualification guidelines (ISO, EN, ICH, FDA, ISPE). Ability to prioritize, manage shifting deadlines, and collaborate cross-functionally; proactive problem-solving mindset. Strong communication, independent work style, and ability to lead in a matrix environment. Preferred
Experience with Staubli robotics technology; Robot Operating Systems (ROS); Artificial Intelligence (AI); Internet of Things (IoT). Other
Requires up to 50% domestic and/or international travel. Compensation
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 are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers.
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