Process Development \ Validation Engineer
Takeda Pharmaceuticals - Bozeman, MT

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  • To design and implement manufacturing processes, instrumentation, and equipment from the laboratory through pilot plant and manufacturing scale up

  • To provide expertise in cell culture, engineering, design, and process and/or scale up

  • To assist the manufacturing operation in problem solving with regard to equipment and systems

  • To develop and recommend new process formulas and technologies to achieve cost effectiveness and improved product quality

  • To recommend processes for the production of therapeutic products


  • Responsible for establishing operating equipment specifications and improving manufacturing techniques

  • Responsible for performing calibration and validation of equipment and systems

  • Responsible for assisting in equipment selection, specifications, and negotiation of competitive pricing

  • Responsible for maintaining documentation pertaining to qualification and validation

  • Responsible for developing procedures and protocols

  • Responsible for serving as information resource for validation contractors and vendors

  • Responsible for participating in new product scale up, process optimization, technology transfer, and process validation activities

  • Responsible for interfacing with all applicable departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology.
    • PHD in chemical or bio-chemical engineering, or equivalent
    • 2 to 4 years of applicable industrial experience
    • Process validation of biological products required
    • GMP engineering experience preferred
    • Manufacturing of biologics experience preferred

    • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
    • May lift up to 50 pounds

    • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
    • Requires approximately 50 % travel.

    We are driven to improve people's lives.

    We are an equal opportunity employer.

    No Phone Calls or Recruiters Please.

    Regular Full-time

    About this company
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