Commissioning & Qualification (CQ) Engineer, Japan New Plasma Facility Project

  • 勤務地
  • 職種
  • 業種


This position will provide support to the execution of commissioning and qualification of a new Plasma manufacturing facility.

This position is responsible to assess and qualify equipment, critical systems (utilities), facilities, computer systems, cleaning processes, manufacturing processes, as applicable. Primary tasks include development of protocols, coordination of commissioning and qualification activities, qualification execution, preparing final reports and assembly of final commissioning and qualification packages, and generation of project plans. Responsibilities will consist of both initial commissioning and qualification efforts as well as re-commissioning and re-qualification. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and will be included in or support regulatory submissions, and made available as needed during internal and external regulatory/compliance audits.

This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis.

Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculums, routine project procedures, project management, and other training as appropriate.

Performs a variety of projects/studies in several areas at the same time to support project timelines and budgets while maintaining quality and compliance.

Supports projects that require team participation. Must demonstrate competent and effective coordination, and organizational skills.

Handles routine tasks with attention to detail, timely and accurately.

Participates and interfaces with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification elements, as applicable, to determine commissioning and qualification strategy based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and qualification. Emphasis is on ensuring accuracy and integrity on commissioning and qualification documentation that meets regulatory guidelines and industry standards.

Writes protocols and reports, executes, interprets, and evaluates commissioning and qualification documents in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, etc.).

Utilizes Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC).

Identifies gaps related to commissioning and qualification requirements and global procedures. May assist in closing compliance gaps as they are identified.

Performs updates to element commissioning and qualification assessments and commissioning and qualification plans, as required.

Participates, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions.

Supports internal or external assessments or audits, as required. Supports process with timely closure of observations/audit items.

Uses commissioning and qualification test equipment in support of commissioning and qualification activities.

Performs other duties as directed by supervisor.

Technical/Functional (Line) Expertise
Must have basic experience in pharmaceutical/biotech commissioning and qualification elements, as applicable, including the writing and executing of protocols and standard operating procedures.

Must have basic knowledge of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus.

Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems.

Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization.

Decision-making and Autonomy
Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving
Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to design, execute and deliver to department goals and project goals.
Must be able to lead and implement optimization of processes within the department or the site.
Must have advanced experience and proficiency in problem analysis and resolution, a successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.
雇用形態 正社員
Typically requires BA or BS degree preferably in the engineering or science field. Ideally 7+ years of commissioning and qualification experience for non mgr role;

Experience in commissioning and qualification of manufacturing processes and control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process equipment, facilities and GMP critical support systems are required.

Experience in commissioning and qualification of a large capital project (e.g. new facility installation) is preferred. Experience in Plasma manufacturing is a plus.

Strong knowledge of risk-based CQ approach (i.e. ISPE Baseline Guide 5 on Commissioning and Qualification) is preferred.

Prior experience in validation and in the use of KNEAT (paperless validation system) is a plus.

Prior experience interacting with the FDA and other regulatory agencies a must.

Will work mostly in office environments with requirements to work in manufacturing and support areas.

Will work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

May work in a hot/cold, wet environment and climb up into large processing tanks.

Will work in Cleanrooms, including cold/hot storage conditions.

May work in a loud area that requires hearing protection and other protective equipment to be worn.

Must have the ability to work in confined spaces (e.g. attic space, engine rooms and tanks).

Will work around chemicals, such as alcohol, acids, buffers, and celite, that may require respiratory protection.

Must be able to work multiple shifts, including weekends and extended hours, as required.

5% travel may be required to other Takeda facilities in order to manage projects related to these facilities or interact with other commissioning and qualification colleagues and/or as part of professional development.

What Takeda can offer you:

Allowances: Commutation, Housing, Overtime Work etc.

Salary Increase: Annually
英語力 ビジネスレベル
年収 600万 〜 1000万円
給与詳細 600万円-1000万円
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.
Takeda isa global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, whichhas been passed down since the company’s founding. Takeda-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.




Microbiology Analyst / 微生物試験担当

職務内容 光工場における製品出品計画を達成するため、原材料・製品に関する微生物学的な試験の実施、試験引継ぎ、SOP・記録書の作成および安定性調査・バリデーションなどに関する試験を行う ・GMP要件に基づく試験(原材料・製品の微生物学的試験) ・査察や監査時の対応 ・試験に関する技術・技能継承 ・公定書、申請書の試験に関連する業務 ・作業改善・効率化に関する業務 ・最新技術(迅速微生物技術等)の導入に関する業務

  • 500万〜800万
  • 山口県
  • 医薬品メーカー(先発医薬品)


Utility Engineer, Japan New Plasma Facility Project

OBJECTIVES/PURPOSE Deliver optimal designs, operating procedures and maintenance programs for GMP and non-GMP Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Maintain accurate, consice, effective, up to date operating procedures and maintenance plans for Plant Utilities Systems / Critical Systems / Site Infrastructure Systems Drive continuous improvements through defect elimination in System Design, Operations and Maintenance program and processes Support Sustainability initiatives related to Plant Utilities Systems (e.g. energy, water, waste reduction) ACCOUNTABILITIES Acting as a Plant Engineer in the Engineering workstream of the project and being the project point of contact with the engineering company for utilities (black and clean) and sustainability related activities. In detail, He/she will: Report to the Engineering Manager. Develop and maintain utility concepts and engineering scope based on the approved budget and schedule. Ensure that all utility systems 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 packages definition related to its discipline. Review and approve design documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals. Manage the resolution of technical issues.

  • 500万〜800万
  • 大阪府
  • 医薬品メーカー(先発医薬品)


Vaccine Environmental Monitoring Staff/ワクチン環境モニタリング担当者(正社員/契約社員)

職務内容 SOPに従いGMP製造エリアでの微生物サンプリング、微粒子サンプリングを含むグレードA~Dクリーンルームの環境モニタリング業務を実行する。 水、蒸気などのクリーンユーティリティーの定常的サンプリング業務を実行する 文書改訂業務、計画書作成または修正時に支援をする。 環境モニタリング計画に従って環境モニタリングを実行する。 逸脱等に対する根本原因の調査を行い、是正・予防計画を含む調査報告書を作成する。 質問や提案を推奨する「Speak Up」を実践する。 環境モニタリング業務や製造エリアの環境に関する改善提案を行う。 コンプライアンスに関する問題を上申する。

  • 300万〜万
  • 山口県
  • 医薬品メーカー(先発医薬品)


Senior Validation SME Manager for Cleaning Validation, Engineering at Hikari Plant

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  • 900万〜1300万
  • 山口県
  • 医薬品メーカー(先発医薬品)