Senior Process Engineer

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OBJECTIVES/PURPOSE:

• Manages technical topics related to the global manufacturing of Drug Product within the scope of VBU Manufacturing Science & Technology.
• Independently develops and implements continuous improvement activities for current and future manufacturing sites within the Takeda vaccines manufacturing network and drives change at internal and external sites.
• Leads resolution of technical issues related to complex Drug Product manufacturing issues and provides technical leadership related to investigations and CAPA, change controls, and during Health Authority inspections.
• Leads technology transfer activities within the scope of Drug Product manufacturing.
• Effectively partners with development, manufacturing, engineering, and quality partners in cross-functional governance meetings.

Champion the integration of AI and digital tools into manufacturing troubleshooting and decision-making.

SCOPE:

• Lead technology transfer projects for vaccine drug products across internal and external manufacturing sites.
• Co-own/develop and drive process validation strategy, including PPQ, CPV, and lifecycle management planning.
• Serve as technical SME for pertinent drug product process stages, e.g., formulation, aseptic filling, lyophilization and/or terminal sterilization, visual inspection and packaging operations processes.
• Design and execute engineering studies and scale-down models for process characterization.
• Lead risk assessments (e.g., pFMEA), deviation investigations, and CAPA implementation.
• Define and manage user requirements for new equipment and participate in qualification activities.
• Collaborate with global stakeholders (CMC, Regulatory, QA, QC, Supply Chain) to ensure alignment and readiness.
• Provide oversight and technical support during health authority inspections and audits.
• Mentor junior engineers and contribute to technical training and capability building.
• Evaluate and implement new technologies and digital tools to enhance process robustness and efficiency.
• Leverage AI and machine learning tools at disposal to analyse large-scale process data for trend identification, predictive maintenance, and anomaly detection.
• Utilize AI-driven modelling and simulation platforms to support process characterization, scale-up, and optimization.
• Work with and support implementation of digital twins and smart analytics to enhance real-time process monitoring and control strategies.
• Collaborate with data science teams to develop custom algorithms for process improvement and deviation prediction.
• Integrate AI-based decision support systems into technology transfer and lifecycle management workflows whenever feasible.
• Promote adoption of automation and intelligent systems in documentation, reporting, and regulatory submissions.
• Stay current with emerging AI technologies relevant to pharmaceutical manufacturing and assess their applicability to vaccine drug product operations.
• Leverage AI and machine learning tools at disposal to analyse large-scale process data for trend identification, predictive maintenance, and anomaly detection.
• Utilize AI-driven modelling and simulation platforms to support process characterization, scale-up, and optimization.
• Work with and support implementation of digital twins and smart analytics to enhance real-time process monitoring and control strategies.
• Collaborate with data science teams to develop custom algorithms for process improvement and deviation prediction.
• Integrate AI-based decision support systems into technology transfer and lifecycle management workflows whenever feasible.
• Promote adoption of automation and intelligent systems in documentation, reporting, and regulatory submissions.
• Stay current with emerging AI technologies relevant to pharmaceutical manufacturing and assess their applicability to vaccine drug product operations.

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#LI-Remote