Senior Process Engineer

Role Summary

Senior Process Engineer responsible for leading technical topics related to global Drug Product manufacturing within Takeda's vaccine network, driving continuous improvement, and providing technical leadership across investigations, CAPA, and health authority inspections. Leads technology transfer activities and partners with development, manufacturing, engineering, and quality in cross-functional governance. Location: Telangana, Virtual.

Responsibilities

• 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.
• 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 to analyze 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.