エージェント取り扱い求人

Senior Process & Utility Engineer, Japan New Plasma Facility Project

募集中
  • 勤務地
    大阪府
  • 職種
    その他製剤化/製造・生産関連職
  • 業種
    医薬品メーカー(先発医薬品)

募集要項

業務内容 OBJECTIVES/PURPOSE

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 company

Engineering and Equipment Design

Safety engineering design and management

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

ACCOUNTABILITIES

Acting as 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 approved budget and schedule.

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

Collaborate with other project disciplines to ensure integrated design solutions.

Guide and coordinate with external design company the procurement strategy packages 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, Black Utilities Operations, Maintenance, Calibration, Reliability, Automation.
雇用形態 正社員
応募資格 Engineering degree or equivalent required; preferably, Chemical, Biochemical, Mechanical or Industrial engineering.

Minimum 5 years of relevant experience.

Expert of Process Unit Operations in Pharmaceutical Manufacturing.

Understanding of Good Manufacturing Practices (GMP).

Preferably, good knowledge / SME for machines/lines/systems and all of its components.

Excellent verbal and written communication skills in English and Japanese.
英語力 問わない
年収 500万 〜 800万円
給与詳細
月額(基本給):310,000円~
<昇給有無>有
<残業手当>有
<給与補足>
※年収は前職の経験を考慮の上、規定により決定します。
■昇給:原則年1回
■賞与:年2回
勤務地 大阪府
備考 ”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us.
global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

企業情報

匿名

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募集中