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Johnson & Johnson Innovative Medicine · 2 days ago

Senior Cell Therapy Engineer

Horsham, PA

Full-time

Onsite

Mid, Senior Level

$94K/yr - $144K/yr

4+ years exp

Johnson & Johnson Innovative Medicine is a leader in healthcare innovation dedicated to developing treatments and cures for complex diseases. They are seeking a Senior Cell Therapy Engineer to act as a decision maker in the Operations Team, responsible for developing supply chain technology and processes for a new facility design while ensuring the successful transfer of the CAR-T process and timely start of clinical/commercial manufacturing.

Pharmaceuticals

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, MES,etc) 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

Qualification

CGMP manufacturingProcess validationCell therapy (CAR-T)Lean supply chain managementTechnical researchAgile decision makingCoachingCorrectivePreventive actionSituational awarenessVendor selectionCritical thinkingProblem solving

Required

Minimum of a Bachelor's or equivalent experience in Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry or related field

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