Senior Cell Therapy Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About Innovative Medicine

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. Learn more at are searching for the best talent for a Cell Processing Staff Engineer to join our team.

The Cell Processing Staff Engineer is part of the Operations Workstream. This role will act as a decision maker in the Operations Team with responsibilities to develop and own set-up of supply chain technology and processes for a new facility design. You will support and implement strategies for change control risk assessments and qualification. By collaborating with various other functions (MSAT R&D Engineering quality assurance quality control health and safety information technology operations planning etc.) you will ensure the successful transfer of the CAR-T process the timely start of clinical/commercial manufacturing and scale out of the facility. The overall goal is creation of a compliant reliable and cost competitive commercial facility.

Key Responsibilities:

At the beginning of the facility design this role will require a broad range of knowledge and will transition to operational readiness and facility startup with ownership of specific areas of the Manufacturing process and all related requirements including the following responsibilities:

• Provide operational expertise based upon a combination of GMP knowledge of facility design knowledge in aseptic techniques and process knowledge in development of technology either in ATMPs or equivalent industry that is transferrable to cell and gene therapy products.

• Provide operational expertise in GMP support processes for instance cleaning environmental monitoring gowning waste GMP documentation needs etc. Translates input into operational performance efficiencies for user requirements for new technology and processes. Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies.

• Provide operational input to the facility resource model. Leverage the model to shape the development and operability of GMP support processes to deliver solutions for cost competitiveness.

• Support development and implementation of change control strategy risk assessment strategy and qualification strategy to ensure operability and scale out considerations within the quality and regulatory requirements.

• Immerse yourself in CAR-T processes build up solid expertise ensure timely development and implementation of a robust operational documentation framework including operating procedures work instructions (electronic) batch records etc. and ensure adequate training of the organization.

• Ensure end-to-end overview of the flow of all material required in your area including process material documents waste samples.

• Identify risks and opportunities in relation to process contamination cross-contamination and mix-up control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators QA QC and operations management.

• Act as a lead in root cause related to safety/quality issues in your area.

• Act as a spokesperson for your area during health care inspections.

• Support the lean design and implementation of Information Technology systems (SAP MESetc) including future releases to continuously improve performance and compliance.

• Develop an appropriate governance structure to monitor the operational performance of your area at acceptance testing startup and ongoing.

• Furthermore a portion of your time will be focused on developing detailed knowledge of the CAR-T production system:

• Develop & maintain in depth understanding of the mfg. processes (incl. 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 understanding of relevant regulatory frameworks (general GMP and specific focus on ATMP)

• Understand biosafety.

Qualifications:

Education:

• Minimum of a Bachelors or equivalent experience in Engineering Bioscience Engineering Industrial Engineering Pharmacy Biochemistry or related field.

Required:

• Minimum 4 years of relevant work experience.

• Experience in one of more of the following areas: cGMP manufacturing operations technology development tech transfer process and equipment validation and/or quality management.

• Ability to collaborate internally and externally within a matrix environment.

• A start-up/can-do attitude and proactively search for solutions.

• 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.

• Work independently and successfully prioritizing and managing multiple tasks simultaneously and integrating cross-functional issues.

• You are able to concisely summarize and present results.

Preferred:

• Experience working in a plant manufacturing environment

• Experience with equipment/systems commissioning/qualification/validation deploying new technology into operations IT/Automation systems cell therapy (CAR-T) is an asset.

Other:

• This position supports a 24/7 dynamic biological manufacturing environment and may involve working in mechanical spaces and on utility systems or gowning into Grade B and C environments.

• Up to 10% domestic/international travel may be required.

• The anticipated compensation range for this position is .

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 and 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 please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is :

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Senior IC