Johnson & Johnson Innovative Medicine
Senior Principal Cell Processing Engineer
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Senior Principal Cell Processing Engineer
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Job Function : Supply Chain Engineering Job Sub Function : Manufacturing Engineering Job Category : Scientific/Technology All Job Posting Locations : Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description : Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 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. 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 CAR-T Cell Processing 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. Key Responsibilities : As CAR-T Engineering System Owner, represent Engineering in Facility & Equipment Design, Qualification and Startup, through transfer to the end user. Create or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, and operational documents. Ownership for equipment / technology – secure relationships with equipment and technology partners to ensure smooth transition from project custody. In partnership with E&PS lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility Participate and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.) 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 During the facility construction phase, participate and support system installations, walkdowns, C&Q and turn-over activities. 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 resolving of technical issues or roadblocks as fast as possible including lessons learned 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, 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 : Minimum of a Bachelor’s or equivalent University Degree required; advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field. Required Experience and Skills : Minimum 8 years of relevant work experience. Experience in Manufacturing Operations and/or Engineering environment Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry Hands-on experience in asset ownership (i.e., equipment, facilities, and utilities) Experience managing and influencing change, including vendor management, change control, and/or asset replacement strategies/activities In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, ISPE) Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met Service mentality and ability to proactively collaborate with teams and partners, working hands-on on aspects of Engineering and asset ownership, while identifying areas of improvement Demonstrated ability to collaborate internally and externally within a matrix environment. Demonstrated start-up mindset, and you proactively search for solutions. You prioritize and provide clear instructions to peers. You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/ guidelines which require strict execution. You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues. Preferred : Experience with equipment / systems commissioning/qualification/validation, Process Automation, IT manufacturing systems, cell therapy (CAR-T) is an asset Other : Requires up to 30% domestic and/or international travel. 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.
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Job Function : Supply Chain Engineering Job Sub Function : Manufacturing Engineering Job Category : Scientific/Technology All Job Posting Locations : Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description : Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 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. 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 CAR-T Cell Processing 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. Key Responsibilities : As CAR-T Engineering System Owner, represent Engineering in Facility & Equipment Design, Qualification and Startup, through transfer to the end user. Create or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, and operational documents. Ownership for equipment / technology – secure relationships with equipment and technology partners to ensure smooth transition from project custody. In partnership with E&PS lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility Participate and have ownership of decisions made in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.) 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 During the facility construction phase, participate and support system installations, walkdowns, C&Q and turn-over activities. 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 resolving of technical issues or roadblocks as fast as possible including lessons learned 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, 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 : Minimum of a Bachelor’s or equivalent University Degree required; advanced degree or focused degree preferred in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field. Required Experience and Skills : Minimum 8 years of relevant work experience. Experience in Manufacturing Operations and/or Engineering environment Experience within Pharmaceuticals, Biopharmaceuticals / Large Molecule, or equivalent industry Hands-on experience in asset ownership (i.e., equipment, facilities, and utilities) Experience managing and influencing change, including vendor management, change control, and/or asset replacement strategies/activities In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, ISPE) Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met Service mentality and ability to proactively collaborate with teams and partners, working hands-on on aspects of Engineering and asset ownership, while identifying areas of improvement Demonstrated ability to collaborate internally and externally within a matrix environment. Demonstrated start-up mindset, and you proactively search for solutions. You prioritize and provide clear instructions to peers. You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/ guidelines which require strict execution. You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues. Preferred : Experience with equipment / systems commissioning/qualification/validation, Process Automation, IT manufacturing systems, cell therapy (CAR-T) is an asset Other : Requires up to 30% domestic and/or international travel. 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.
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