Johnson & Johnson Innovative Medicine
Senior Principal Cell Processing Engineer
Johnson & Johnson Innovative Medicine, Raritan, New Jersey, us, 08869
Overview
Join to apply for the
Sr Principal Cell Processing Engineer
role at
Johnson & Johnson Innovative Medicine . This hybrid position can be based in Titusville, New Jersey; Spring House, Pennsylvania; 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. JJIM is working to develop, manufacture, and commercialize products in the CAR-T space. Johnson & Johnson Innovative Medicines, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Principal – Cell Processing Engineer. Our CAR-T Engineering organization provides ownership and oversight for the entire asset portfolio and associated business processes for JJIM’s Advanced Therapies Supply Chain. 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. 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. Own equipment / technology – secure relationships with equipment and technology partners to ensure smooth transition from project custody. Lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility. Participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.) and own related decisions. Support development of an 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 in system installations, walkdowns, C&Q and turnover activities. Develop asset management procedures, preventive maintenance and calibration. Drive standards for the asset portfolio and provide asset ownership as a service for production / laboratory equipment, facilities, and clean/GMP utilities. Oversee all stages of asset lifecycle, including replacement planning and vendor evaluation / selection. Support resolving technical issues or roadblocks quickly and share lessons learned. Support investigations, deviations, corrective and preventive actions toward timely and compliant closure. Participate in compliance inspections / audits within area of responsibility and ensure adherence to all applicable cGMPs, 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. Part of the role will focus on developing detailed knowledge of CAR-T production processes, including aseptic and cell processing techniques, robotics and automation, and relevant regulatory frameworks (GMP and ATMP). Qualifications
Education : 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. 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 (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 workload and adapt to shifting priorities to meet business needs. Service mindset with ability to collaborate across teams and work hands-on on engineering and asset ownership while identifying improvement opportunities. Ability to collaborate internally and externally within a matrix environment; startup mindset and proactive problem solving. Ability to work independently, manage multiple tasks, and integrate 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. 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 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. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. 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, internal employees contact AskGS to be directed to your accommodation resource. Careers - Contact us
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Join to apply for the
Sr Principal Cell Processing Engineer
role at
Johnson & Johnson Innovative Medicine . This hybrid position can be based in Titusville, New Jersey; Spring House, Pennsylvania; 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. JJIM is working to develop, manufacture, and commercialize products in the CAR-T space. Johnson & Johnson Innovative Medicines, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Principal – Cell Processing Engineer. Our CAR-T Engineering organization provides ownership and oversight for the entire asset portfolio and associated business processes for JJIM’s Advanced Therapies Supply Chain. 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. 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. Own equipment / technology – secure relationships with equipment and technology partners to ensure smooth transition from project custody. Lead engagement with vendor, factory acceptance testing (FAT) / site acceptance testing (SAT) within system of responsibility. Participate in safety reviews (EHS by Design, HAZOPs, machine safety, ergonomics, etc.) and own related decisions. Support development of an 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 in system installations, walkdowns, C&Q and turnover activities. Develop asset management procedures, preventive maintenance and calibration. Drive standards for the asset portfolio and provide asset ownership as a service for production / laboratory equipment, facilities, and clean/GMP utilities. Oversee all stages of asset lifecycle, including replacement planning and vendor evaluation / selection. Support resolving technical issues or roadblocks quickly and share lessons learned. Support investigations, deviations, corrective and preventive actions toward timely and compliant closure. Participate in compliance inspections / audits within area of responsibility and ensure adherence to all applicable cGMPs, 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. Part of the role will focus on developing detailed knowledge of CAR-T production processes, including aseptic and cell processing techniques, robotics and automation, and relevant regulatory frameworks (GMP and ATMP). Qualifications
Education : 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. 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 (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 workload and adapt to shifting priorities to meet business needs. Service mindset with ability to collaborate across teams and work hands-on on engineering and asset ownership while identifying improvement opportunities. Ability to collaborate internally and externally within a matrix environment; startup mindset and proactive problem solving. Ability to work independently, manage multiple tasks, and integrate 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. 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 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. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. 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, internal employees contact AskGS to be directed to your accommodation resource. Careers - Contact us
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