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Job Description
OBJECTIVES/PURPOSE
- Execute GMP remediation activities at Narita plant.
- Lead and support Narita extension program activities.
- Improve Narita production processes to increase productivity.
- CAPEX project management focused on improving the effectiveness and efficiency of CAPEX projects at Narita plant.
- Responsible for executing CAPEX projects from feasibility study to end of qualification (OQ).
- Apply investment plan, cost estimation, budget control, schedule control, quality control for project matters, and risk management during projects.
- Support capital projects as needed.
- Provide technical support to manufacturing and maintenance functions for equipment and processes.
ACCOUNTABILITIES
- Develop yearly CAPEX plan, BOMs, and frequencies for new and modified equipment.
- Perform review and maintain projects for CAPEX in Narita.
- Interact with Global Engineering team to build standards across the network and provide input to Divisional Procedures efficiently.
- Participate in internal and external regulatory audits.
- Track and routinely present group performance objectives to head of engineering; review, assess, and counsel engineering project teams regarding all areas of impact, such as layout, design for maintainability, component standardization, and spare parts/material optimization under GMP governance.
- May assist in the preparation of and/or participation in technical reviews of equipment design projects.
- May be assigned change control, Quality CAPA, and Safety CAPA tasks.
- Participate with Operations to develop and improve Equipment Reliability, Preventive/Predictive Maintenance, and CMMS Data Collection and Operation.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Extensive experience with GMP and current best practices for asset management including, Preventive Maintenance, Reliability Engineering, RCM, FMEA etc.
- Understanding industrial hazards and Process Safety Management and Mechanical Integrity Program principles is a requirement.
- Must possess knowledge of the core engineering principles: heat transfer, mass transfer, thermodynamics, and fluid mechanics.
- Familiarity with Biotechnology manufacturing operations such as Cell Culture, purification, aseptic filling, packaging, and their support systems such as CIP, SIP, HVAC, plant, and clean utilities, is a plus.
Leadership
- Passion for Improving Lives: Must be able to put our patients at the center of everything we do.
- Inspired Teams environment: Must be able to thrive in diverse high performing teams.
- Engaged with the World around Us: Must be able to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
- Demonstrated success in delivering results in several technical challenges.
- The candidate must have good communication skills and the ability to perform effectively in multi-disciplinary teams.
- Demonstrate Takeda leadership behaviors as engineering leadership team
Decision-making and Autonomy
- Making a engineering related financial & operational decisions to positively impact both short & long-term site goals
- While the strategy & policies of Global Engineering and Narita Plant are determined, can set concrete goals and milestones as Narita Engineering, be required to decide all the tactics how to achieve each goal
Interaction
- Creating, developing and maintaining relationships not only with relevant departments of GMSGQ Japan but also with Global Engineering, other associate divisions and external experts, in order to promptly implement various engineering measures at Narita Plant
- Ensuring the sharing and application of best practices and expertise within own department and sharing with the wider global network
Innovation
- Quest for Innovation: Must be able to operate with agility and a learning mindset so that we can accelerate breakthrough innovations.
- Identifying and implementing strategic opportunities to drive cost reductions / process improvements in manufacturing operations
- Developing and maintaining a comprehensive GMP facilities master plan to optimize resources
- Leading and engaging own members with the AGILE program to drive continuous improvements
- Invest state of art technology but no over engineering
Complexity
- Coordinating engineering strategic matters with Global Engineering and each department in Narita Plant / Narita Site Quality
- Collaborating with cross functional leaders to identify and prioritize facilities and equipment requirements for manufacturing, laboratories, potentially office space.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s degree or Master's degree of Engineering
- At least +10 years experiences of engineering,
- Must have people and organization management experience
- Must have business level of English verbal communication ability and reading/ writing skills in English
Preferred
- Experience of working in overseas countries
- Experience of working in other function such as production, technology operation, quality assurance and so on.
ADDITIONAL INFORMATION
- This position offers an experienced individual a significant opportunity to establish best practices for Engineering of GMP manufacturing operations and packaging.
- Some travels will be required
- This job description is not designed to be a complete list of all duties and responsibilities required of the position.
Takeda Compensation and Benefits Summary:
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually, Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
Locations
JPN - Chiba - Narita Plant
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time