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Job Description:
The Principal Engineer - EG Process will oversee the project management of assigned area main process and auxiliary equipment for Filling Line 2, guiding the initiative from procurement through to APS completion. This role will leverage strategies for replicating the successful designs and Commissioning & Qualification (C&Q) approaches from Line 1 and network sites, ensuring timely delivery and seamless project execution. As the Subject Matter Expert (SME) for equipment, the role will manage the UR and TS creation and design confirmation, oversee equipment fabrication and lead C&Q activities, and address technical challenges throughout the project lifecycle.
Key Responsibilities:
Collaborate with the project manager to ensure the project is adequately resourced.Develop the project plan, timelines, and resource allocation. Manage the overall planning, coordination, and execution of the project from design to completion to meet the objectives.Oversee the equipment design, fabrication, installation, commissioning, and qualification of systems, ensuring compliance with safety, performance, regulatory, and Lilly standards.Manage the project budget and be responsible for cost control in the scope.Identify, evaluate, and mitigate project risks, ensuring that potential delays or challenges are addressed proactively.Escalate issues timely to minimize the project’s impact.Provide regular project updates and facilitate project meetings.Ensure proper document management, including project files, C&Q documents, and procedures.Leverage lessons learned from previous projects to improve performance and minimize risks on the current project.Utilize best practices from Filling Line 1 and network sites to replicate effective designs and C&Q approaches, ensuring efficient project execution and lead time management. Documents the difference between Filling Line 1 and new design, get the approval from steering groups while needs.Oversee the design confirmation process, ensuring all equipment meets operational and compliance requirements.Act as the SME for equipment-related UR creation and design confirmation, providing insights and guidance to the project team.Engage in technical problem-solving and troubleshooting, addressing any issues that arise during design, procurement, installation and qualification phases.Oversee C&Q activities for process and auxiliary equipment, ensuring all systems meet regulatory and operational standards.Manage system change control.Complete other tasks as assigned by the manager.Requirements:
Bachelor’s degree or higher in Engineering (Chemical, Mechanical, or related field) is required.Minimum of 8-10 years of experience in process engineering pharmaceutical or related industries.In-depth knowledge of process and auxiliary equipment, with experience in pararenal operations and design best practices.Proficiency in C&Q methodologies, regulatory compliance standards and Lilly requirements.Project management experience, and participation in large-scale projects.Experience in pharmaceutical manufacturing with a strong understanding of GMP, regulations, and Lilly standards and practices.Collaborative mindset with a proactive approach to problem-solving and project execution.Proficient in both Chinese and English for communication and documentation.Knowledgeable about Lilly HSE and related regulations.Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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