Johnson & Johnson Innovative Medicine
Senior Principal Cell Processing Engineer
Johnson & Johnson Innovative Medicine, Titusville, New Jersey, us, 08560
Overview
Senior Principal CAR-T Cell Processing Engineer role at Johnson & Johnson Innovative Medicine. This hybrid position can be based in Titusville, NJ; Spring House, PA; or Raritan, NJ. The CAR-T Engineering organization provides ownership and oversight for the asset portfolio and related business processes for JJIM’s Advanced Therapies Supply Chain. The engineer serves as the technical owner of cell processing systems, collaborating with multiple functions to ensure design, qualification, startup, operations, and asset lifecycle activities meet program needs. Key Responsibilities
As CAR-T Engineering 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. Write or support User Requirement Specifications (URSs), Change Controls, Impact Assessments, technical evaluations, and operational documents; ensure business requirements are incorporated and obtain business owner approval. Own equipment/technology relationships to ensure smooth transition from project custody. Engage with vendors for factory acceptance testing (FAT) and site acceptance testing (SAT) within the system of responsibility. Participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics) and support development of integrated process data map and criticality assessments for automation and manufacturing deliverables. Manage cost and resources within systems of responsibility; participate in system installations, walkdowns, qualification/commissioning (C&Q) and turnover activities during facility construction. Develop asset management procedures, preventive maintenance, and calibration regimes; drive standards for the asset portfolio and provide asset ownership as a service for production/laboratory equipment and facilities. Support asset lifecycle activities including replacement planning and vendor evaluation/selection; assist with technical issue resolution and lessons learned; participate in compliance inspections/audits; ensure compliance with cGMPs and regulatory requirements. Communicate regularly with the Engineering community and foster cross-site knowledge sharing with CAR-T entities globally; analyze processes to identify optimization opportunities, efficiency gains, and cost savings. Additionally, develop in-depth knowledge of CAR-T production processes and regulatory frameworks relevant to GMP and ATMP. Qualifications
Education Minimum of a Bachelor’s degree; advanced or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field. Experience and Skills Minimum 8 years of relevant work experience in Manufacturing Operations and/or Engineering; experience in Pharmaceuticals/Biopharmaceuticals or related industry; hands-on asset ownership experience; knowledge of GMP standards and commissioning/qualification guidelines (ISO, EN, ICH, FDA, ISPE); ability to manage shifting priorities; strong collaboration and change-management skills; ability to work in a matrix environment; startup mindset and ability to lead under changing conditions. Travel Requires up to 30% domestic and/or international travel. Preferred Experience with equipment/system commissioning/qualification/validation, process automation, IT manufacturing systems; experience in cell therapy (CAR-T) is an asset. Additional Information
The anticipated base pay range for this position is $127,500 to $172,500. 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 law. Reasonable accommodation requests can be directed via the Careers site.
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Senior Principal CAR-T Cell Processing Engineer role at Johnson & Johnson Innovative Medicine. This hybrid position can be based in Titusville, NJ; Spring House, PA; or Raritan, NJ. The CAR-T Engineering organization provides ownership and oversight for the asset portfolio and related business processes for JJIM’s Advanced Therapies Supply Chain. The engineer serves as the technical owner of cell processing systems, collaborating with multiple functions to ensure design, qualification, startup, operations, and asset lifecycle activities meet program needs. Key Responsibilities
As CAR-T Engineering 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. Write or support User Requirement Specifications (URSs), Change Controls, Impact Assessments, technical evaluations, and operational documents; ensure business requirements are incorporated and obtain business owner approval. Own equipment/technology relationships to ensure smooth transition from project custody. Engage with vendors for factory acceptance testing (FAT) and site acceptance testing (SAT) within the system of responsibility. Participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics) and support development of integrated process data map and criticality assessments for automation and manufacturing deliverables. Manage cost and resources within systems of responsibility; participate in system installations, walkdowns, qualification/commissioning (C&Q) and turnover activities during facility construction. Develop asset management procedures, preventive maintenance, and calibration regimes; drive standards for the asset portfolio and provide asset ownership as a service for production/laboratory equipment and facilities. Support asset lifecycle activities including replacement planning and vendor evaluation/selection; assist with technical issue resolution and lessons learned; participate in compliance inspections/audits; ensure compliance with cGMPs and regulatory requirements. Communicate regularly with the Engineering community and foster cross-site knowledge sharing with CAR-T entities globally; analyze processes to identify optimization opportunities, efficiency gains, and cost savings. Additionally, develop in-depth knowledge of CAR-T production processes and regulatory frameworks relevant to GMP and ATMP. Qualifications
Education Minimum of a Bachelor’s degree; advanced or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field. Experience and Skills Minimum 8 years of relevant work experience in Manufacturing Operations and/or Engineering; experience in Pharmaceuticals/Biopharmaceuticals or related industry; hands-on asset ownership experience; knowledge of GMP standards and commissioning/qualification guidelines (ISO, EN, ICH, FDA, ISPE); ability to manage shifting priorities; strong collaboration and change-management skills; ability to work in a matrix environment; startup mindset and ability to lead under changing conditions. Travel Requires up to 30% domestic and/or international travel. Preferred Experience with equipment/system commissioning/qualification/validation, process automation, IT manufacturing systems; experience in cell therapy (CAR-T) is an asset. Additional Information
The anticipated base pay range for this position is $127,500 to $172,500. 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 law. Reasonable accommodation requests can be directed via the Careers site.
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