Description
Better Health for People, Brighter Future for the World is the purpose of a company. 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're looking for like-minded professionals to join us.
Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company's founding. Takeda-ism incorporates and with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
Job Summary
• This position is a member of the Global Project Team for the construction of factories and is responsible for supporting the commissioning, qualification, and validation strategy implementation, and performing the same.
• This position is responsible for evaluating, verifying, and confirming the suitability and validity of facilities, systems, and equipment/devices in construction projects while cooperating with engineering personnel, and is the primary responsibility for overall planning of qualification/validation, implementation of risk assessment, creation of verification plan documents, implementation and execution of verification, creation of verification report documents, etc. In addition, the position is also responsible for investigating, improving, and re-verification of failures of facilities, systems, and equipment/devices while cooperating with engineering personnel. These results will be archived, included in submissions to regulatory authorities, or used to support them, and may be used as needed during internal and external regulatory/compliance audits.
• The position will work closely with various departments such as engineering, manufacturing, quality assurance, quality control, supply chain, EHS, etc. on a daily basis.
Job Responsibilities
• Each relevant GxP requirements, pharmacopoeia, ISPE Baseline Guide, etc. and company internal related guidelines/standards/SOP, and acquire sufficient understanding and mastery.
• Based on the concept of lifecycle approach (user requirements specification, risk assessment, commissioning/qualification/validation) for construction projects, discuss, plan, and decide the commissioning/qualification/validation strategy implementation together with cross-functional team members (engineering, manufacturing, quality assurance, quality control, supply chain, EHS, etc.) and ensure that qualification/validation activities are properly implemented based on risk, and meet the requirements of relevant guidelines and company internal related guidelines/standards/SOP.
• Collaborate with relevant engineering personnel to plan, execute, and adjust project implementation and commissioning/qualification/validation plans with stakeholders inside and outside the company.
• Collaborate with relevant engineering personnel to investigate, improve, and re-verify the causes of failures of facilities, systems, and equipment/devices.
• Use document management systems (SharePoint, Kneat, Veeva Vault, etc.) to manage documents related to commissioning/qualification/validation.
• Identify gaps in company global qualification/validation procedures related to the project and handle and resolve them.
• Other daily related work is handled in a timely and proper manner.
• As needed, respond to internal and external audits and inspections, and support timely completion of observation/audit items.
• Follow the instructions of the superior and perform other necessary work.
Job Scope and Features
Technical/Jurisdictional (Line) Specialty
• Basic knowledge and experience in commissioning/qualification/validation for construction projects.
• Basic knowledge of GxP (particularly GMP) regulatory environment. Experience in engineering, manufacturing, and technical services departments related to pharmaceutical manufacturing is desirable.
• Ability to logically interpret pharmaceutical quality systems and related laws and guidelines.
Leadership
• Excellent organizational skills, ability to pursue and resolve technical challenges, analyze solutions, plan and execute improvement plans.
• Excellent interpersonal/communication/influence/negotiation skills/organizational/prioritization skills as a leader and project manager.
Decision-Making and Autonomy
• Ability to manage tasks, make decisions, resolve challenges, grant permissions to others, provide training and education, and manage teams appropriately.
Interoperability
• Ability to closely cooperate with SMEs in various departments such as engineering, manufacturing, quality assurance, quality control, supply chain, and EHS to plan, execute, and achieve departmental and project goals.
Innovation
• Ability to lead and implement optimization and efficiency of commissioning/qualification/validation for construction projects.
Complexity
• Experience in resolving challenges, setting hypotheses, identifying causes/root causes, logical analysis, and successful resolution of challenges. Also, high speed decision-making ability and ability to resolve multiple challenges are required.
Education, Behavior Ability, and Skills
• Bachelor's degree or higher in engineering or science fields, or equivalent knowledge.
• 5 years or more of experience in design/implementation of processes, facilities, systems, equipment/devices related to pharmaceutical manufacturing or medical devices. Experience in designing/introducing clean rooms, aseptic pharmaceuticals, or biopharmaceuticals is desirable.
• Knowledge and experience of laws and guidelines related to regulatory authorities on pharmaceutical manufacturing or medical devices. Knowledge and experience of laws related to aseptic pharmaceuticals or biopharmaceuticals is desirable.
• 3 years or more of experience in commissioning/qualification/validation is desirable.
• Experience in large-scale factory construction projects is desirable.
• Ability to communicate in Japanese and English on a business level.
Addition Information
• Primarily works in an office environment, but may work in manufacturing areas or support areas.
• May work in a controlled environment that requires special gowning. Follow the requirements of gowning and wear protective clothing for heads, faces, hands, feet, and bodies.
• May not wear makeup, jewelry, contact lenses, nail polish, or artificial nails in manufacturing environments.
• May work in high temperature, low temperature, high humidity, or low humidity environments.
• May work in clean rooms with low temperature storage conditions.
• May work in noisy areas that require wearing hearing protection gear.
• May work in closed spaces (roof spaces, tanks, etc.).
• May handle chemicals such as alcohol, acid, buffer, and sealer that require wearing protective gear.
• As needed, may work on multiple shifts, including weekends and overtime.
• As needed, may work remotely.
• As needed, may be required to travel to other Takeda sites to manage related projects, interact with validation personnel at other sites, or develop professional skills.
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:
• 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.
Locations
Osaka (Juso), Japan
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

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