Job Title: Global Validation Engineer
We are seeking a highly motivated and experienced Global Validation Engineer to join our Engineering Services Group in Hikari, Japan.
About Takeda
Takeda is a global values-based, R&D-driven biopharmaceutical leader. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients.
We are guided by our values of Takeda-ism, which has been passed down since the company's founding. Takeda-ism incorporates Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
About the Role
This role will be responsible for implementing GxP requirements into local SOPs/Forms, establishing systems for new requirements, planning and scheduling for new requirements, providing training, managing documents, and collaborating with various members to achieve business objectives.
Key Responsibilities:
- Implementing latest CQV requirements from Global SOPs/Industry Standards (GMP, FDA Guidelines) and legal regulatory requirements related to drug manufacturing processes in the factory.
- Establishing local SOP/Forms updates, system establishment for new requirements, and implementation of new process.
- Planning, scheduling, and providing training for new requirements.
- Explain and obtain agreement from related departments such as Quality, Manufacturing, and Manufacturing Engineering regarding new requirements and future initiatives.
- CQV document management.
- Maintaining and updating Kneat System with Global Team and Factory Users.
Requirements:
- Knowledge of qualification or validation of manufacturing processes, equipment, facilities, utilities, or important support systems for GMP.
- Experience in using English in a business environment.
- Bachelor's degree or higher.
- Experience in qualification/validation of any process (equipment, cleaning, sterilization, computerized system, and control system).
- More than 5 years of experience in validation work.
- Experience interacting directly or indirectly with FDA and other regulatory agencies.
About Takeda Compensation and Benefits
- 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:
- It is possible the job scope may change at the company's discretion.
- It is possible the department and workplace may change at the company's discretion.
Location: Hikari, Japan
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
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