Principal Engineer, Technical Operations

- Serve as a senior technical expert within Technical Operations, providing comprehensive lifecycle support for products, processes, and systems. - Ensure alignment between Manufacturing, Engineering, and Quality for optimized operations globally. - Drive continuous improvement and technology stewardship while aligning with enterprise strategies and global standards. - Provide technical leadership and lifecycle expertise to maximize process and product performance. - Act as a resource for complex manufacturing and engineering inquiries. - Lead or support technology transfers, modernization efforts, and lifecycle management initiatives. - Troubleshoot operational issues using structured methodologies and data analytics. - Ensure timely resolution of deviations, CAPAs, change controls, and regulatory commitments. - Analyze production data to detect trends, risks, and opportunities for improvement. - Utilize risk assessment tools during validation and design decisions. - Lead or support S&I and OPEX/CAPEX projects, maintaining compliance with industry standards. - Contribute to the development of process documentation, user requirements, and conceptual designs. - Identify and implement continuous improvement projects focused on yield, quality, reliability, efficiency, and cost effectiveness. - Support the creation of standardized processes and best practices for global harmonization. - Develop and execute effective validation strategies for systems, processes, and equipment. - Prepare comprehensive documentation for regulatory submissions. - Assist during internal and external audits and inspections, providing technical support. - Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, and R&D to facilitate enterprise-wide standards. - Act as a safety role model, adhering to all guidelines and promoting a culture of safety excellence.