Drug Substance Process Engineer - Technology Deployment
Johnson & Johnson is currently recruiting for a Drug Substance Process Engineer - Technology Deployment located in Titusville, NJ; Geel, BE; or Beerse, BE!
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Job Summary:
We are seeking a highly skilled and experienced Drug Substance Process Engineer to join our team. As the Process Engineer, you will lead the deployment of technology, both internally and externally, to enhance our drug substance manufacturing processes. Your expertise in process optimization, process analytical technology, modeling, and data analytics will be instrumental in driving continuous improvement and innovation in our drug substance manufacturing operations.
Responsibilities:
- Lead the deployment and utilization of innovative manufacturing technologies for drug substance production, both internally and by scouting external collaborations and partnerships.
- Develop and optimize drug substance manufacturing processes, ensuring robust and efficient operations through the use of advanced technologies and methodologies.
- Utilize modeling, simulation, and data analytics techniques to analyze process data, identify areas for improvement, and implement strategies to enhance yield, purity, and efficiency.
- Lead small-scale and pilot-scale process development activities, including design of experiments (DoE), process characterization, and process scale-up.
- Collaborate with cross-functional teams, including Research and Development, Engineering, and Quality Control, to ensure seamless technology transfer and smooth integration of new technologies into manufacturing operations.
- Proactively evaluate emerging technologies and process improvements in the drug substance manufacturing field, providing recommendations for implementation and advancement.
- Develop partnerships and collaborations with external vendors, technology providers, and academic institutions to leverage the latest advancements and expertise in drug substance manufacturing.
- Lead or participate in the scale-up and tech transfer of drug substance manufacturing processes from development to commercial production.
- Develop and maintain comprehensive documentation, including process development reports, standard operating procedures (SOPs), and batch records.
- Ensure compliance with regulatory requirements and industry standards for drug substance manufacturing, including cGMP.
- Provide technical support to manufacturing teams, troubleshoot process issues, and implement corrective actions as needed.
- Proactively engage in continuous learning and professional development to stay updated on the latest advancements and trends in drug substance manufacturing technology.