■Position Summary & Job Description
Lead the engineering design, installation, commissioning, qualification, and operational readiness of Fill & Assembly production lines to ensure safe, compliant, cost-effective, and timely project delivery. Responsible for technical leadership, stakeholder alignment, contractor management, and successful startup of automated manufacturing and packaging systems.

■Key Responsibilities
General Leadership & Technical Management
•Ensure Fill & Assembly line readiness to achieve project objectives related to Safety, Quality, Delivery, Cost, and Performance.
•Develop and execute the technical learning and capability-building strategy for the engineering team, fostering a culture of innovation, continuous improvement, and smart risk-taking.
•Coach, mentor, and develop engineering leads and sub-team leaders, enabling them to achieve project deliverables while proactively removing barriers to success.
•Provide technical leadership throughout the project lifecycle, from concept development through commissioning and validation.
•Manage engineering scope execution with Engineering Excellence teams, design consultants, system integrators, and equipment suppliers.
•Ensure compliance with company engineering standards, regulatory requirements, machine safety standards, and industry best practices.
•Support project governance processes and provide technical recommendations to facilitate timely decision-making.

■Scope Management
•Own and deliver the approved project scope and business intent as defined in the Project Charter for the Fill & Assembly area.
•Develop and maintain the Scope Summary Document throughout all project phases.
•Lead technical discussions, reviews, and decision-making processes within the area of responsibility.
•Ensure engineering deliverables meet project objectives, operational requirements, quality standards, and regulatory expectations.
•Drive technical reviews to verify design integrity, manufacturability, maintainability, operability, reliability, and safety.
•Manage interfaces between Fill & Assembly systems and adjacent functions including Compounding, Utilities, Warehousing, Automation, Quality, and Operations.
•Identify scope gaps, technical risks, and opportunities, and implement mitigation plans.

■Cost Management
•Accountable for managing and controlling capital expenditures within the Fill & Assembly engineering scope.
•Collaborate with Cost Engineering to establish and maintain a detailed Cost Breakdown Structure (CBS).
•Provide timely and accurate cost information to support monthly forecasting, cost trending, and project financial reporting.
•Participate in weekly project reviews and monthly cost governance meetings.
•Continuously identify opportunities for cost optimization, value engineering, and schedule acceleration without compromising safety, quality, or performance.
•Evaluate, negotiate, and challenge contractor, supplier, and vendor proposals to ensure best value for the project.
•Ensure all scope modifications impacting cost or schedule are managed through the approved Change Management process.
•Support procurement and contracting activities including technical bid evaluations and vendor selection.

■Schedule Management
•Develop, review, and maintain engineering, procurement, installation, commissioning, and qualification schedules for Fill & Assembly systems.
•Coordinate with engineering consultants, contractors, equipment suppliers, and project controls teams to ensure schedule alignment.
•Monitor critical path activities and proactively implement corrective actions to recover schedule deviations.
•Identify schedule risks and develop mitigation plans to maintain project milestones.
•Support integrated project planning and resource allocation activities.

■Safety, Quality & Compliance
•Champion a zero-harm safety culture throughout engineering, construction, commissioning, and startup activities.
•Ensure compliance with Japan Industrial Safety regulations, company EHS requirements, and applicable international standards.
•Lead construction and installation safety activities including:
　oRisk Assessments
　oMethod Statements
　oBehavioral Observation Safety (BOS)
　oPermit-to-Work Systems
　oContractor Safety Management
•Ensure all engineering and installation activities comply with applicable GMP, quality, and validation requirements.
•Drive implementation of machine safety principles and risk reduction measures.
•Participate in safety audits, design reviews, hazard analyses, and incident investigations.