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Senior Process Engineer, Japan New Plasma Facility Project

Jūsō-honmachi, Ōsaka
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On the Global Manufacturing and Supply (GMS) team at Takeda, you’ll be part of a rapidly transforming industry that’s applying technology and data in new ways. Within our agile, innovative, people-centric organization, your work will matter every day as you use your skills to help us manufacture therapies for patients on our four platforms:

  • Small Molecules
  • Biologics
  • Plasma
  • Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0097896 Date posted 06/07/2023 Location Jūsō-honmachi, Ōsaka

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Job Description


  • Ensure Process Equipment is “fit for purpose” for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements

  • Main objectives (key services)

    • Technology selection

    • Review Capacity Modeling developed by Engineering companies

    • Engineering and Equipment Design

    • Safety engineering design and management

  • Recommend future strategic preparations for the project by introducing new process technologies such as robotics and delivering agile process engineering solutions


  • Acting as a Process Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for process equipment.

In detail, He/she will:

  • Report to the Engineering Manager.

  • Develop and maintain process equipment concepts and engineering scope based on the approved budget and schedule.

  • Ensure that all process equipment meet regulatory requirements, client specifications, and industry standards, and defines the user requirements.

  • Collaborate with other project disciplines to ensure integrated design solutions.

  • Guide and coordinate with the external design company on the procurement strategy and procurement package definition related to its discipline.

  • Review and approve design documents and concepts.

  • Conduct gate keeping reviews.

  • Review and approve contractor submittals.

  • Lead commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment.

  • With Partners in Engineering Validation support the Qualification and Validation activities for Process Equipment.

  • Perform Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Utilities Operations, Maintenance, Calibration, Reliability, Automation.


  • Manufacturing/Production, Utilities Operations, Instrument Calibration/Metrology, Spare Parts Manager, EHS, Engineering, Reliability Engineering, Sustainability Engineer


  • Engineering degree or equivalent required; for example Chemical, Biochemical, Mechanical or Industrial engineering is preferred

  • Minimum 5 years of relevant experience

  • Expert of Process Unit Operations in Pharmaceutical Manufacturing

  • Understanding of Good Manufacturing Practices (GMP)

  • Good knowledge / SME for machines/lines/systems and all of its components is preferred

  • Excellent verbal and written communication skills in English and Japanese


Osaka (Juso), Japan

Worker Type


Worker Sub-Type


Time Type

Full time
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About our location

Jūsō-honmachi, Ōsaka

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