Coordinator, Spare Parts, Engineering, / エンジニアリング スペアパーツ コーディネーター(契約社員)
-
勤務地山口県
-
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 |
募集部門の紹介 医薬品製造工場の設備(建築、機器、空調、配管、電気、計装)に関するオーナーズ・エンジニアリング業務(自社の立場に立ったエンジニアリング業務)を実施している部門です。 職務内容 予備部品管理者/管理者の指示の下、予備部品及び保全資材の受領、保管、移動を含む、効率的かつ効果的な日常の物品管理活動 予備品倉庫/保管室の物理的セキュリティの日常的なモニタリング及びすべてのセキュリティ関連の問題の管理者への報告 Efficient and effective daily warehouse activities, including the receipt, storage, staging and movement of spare parts and maintenance materials under direction of Spare Parts Supervisor / Manager Day-to-day monitoring of physical security in the spare parts warehouse/storeroom and the reporting of all security-related issues to management |
---|---|
雇用形態 | 契約社員 |
応募資格 |
<実務経験> 物品保管管理のトレーニング受講または経験があることが望ましい。 医薬品の製造管理及び品質管理に関する基準(GMP)の経験があると望ましい。 PCを使った業務ができること。エクセル・ワード・パワーポイント等。 Material planning/warehouse management training and/or experience. Familiar with Good Manufacturing Practice (GMP). PC Skills to work with MS Excel, Word, PowerPoint, etc. <その他> 優れた業務スキルと柔軟性を示すことができること 在庫管理を理解し適用できること チームで働き、維持/生産目標と目標をサポートすることができること Demonstrates good work skills and flexibility in assignments. Understands and apply inventory management best practices. Works in a team environment, supporting maintenance/production goals and objectives. 求める人物像 明るくへこたれない。 経験がなくても、自分で考え、自律的に行動ができる。 細かな作業をやり遂げることができる。 仕事のやりがい 中でも有数の生産拠点である光工場で、安定生産の鍵を握るメンテナンス&リライアビリティの部品管理スペシャリストになれる業務です。 本職務で身につくスキル・経験 予備品のような物品管理のスキルが身につけられます。また、単なる管理業務ではなく、ご自身の知恵や工夫により改善活動にも取り組んでいただけるので、クリエイティブな業務スタイルの習得にもチャレンジしていただけます。 |
英語力 | 問わない |
年収 | 300万 〜 万円 |
給与詳細 |
<賃金内訳> 月額(基本給):197,000円~ <昇給有無>有 <残業手当>有 <給与補足> ※給与はキャリア・能力等を考慮の上、当社規程により決定 ・昇給年1回 ・賞与年2回 |
勤務地 | 山口県 |
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
関連する求人
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.
- 500万〜800万
- 大阪府
- 医薬品メーカー(先発医薬品)
募集中
OBJECTIVES/PURPOSE 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. ACCOUNTABILITIES 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. DIMENSIONS AND ASPECTS 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. Leadership 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 Interaction 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. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity 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.
- 600万〜1000万
- 大阪府
- 医薬品メーカー(先発医薬品)
募集中
職務内容 工場の改善活動(AGILEプログラム)の推進リーダーとして以下の業務を遂行する。 1.工場の改善活動での工場の優先課題解決をリードする: 工場戦略実現のための優先事項に対する活動を現場メンバーと共に推進し、積極的に展開する 改善を推進する手法と様々なデジタルツールを習得する 2.多岐に渡る関係部門とのコラボレーションを図る: グローバルを含めた他工場、日本国内の多業種他社から改善のベストプラクティス事例を吸収し、工場内に共有し展開する 工場内やグローバル各工場に在籍する他の改善推進者と協力し合いながら、改善を推進する 改善成果発表会(国内外あり)での機会を活用して、多くの人たちとの信頼関係を築く 3.必要なコーチングの実践: 改善活動では「マインドセットとカルチャーの変革」を一つの重要なコンセプトとしており、工場リーダーシップを含む全従業員に対して常に「マインドセットと行動」の変革を促す 工場で開催されるトレーニングやワークショップへの参加を通じて、自分自身がファシリテーターとなったり、コーチングを実践する
- 500万〜800万
- 山口県
- 医薬品メーカー(先発医薬品)
募集中
将来の大阪工場のサイトマスタープランに基づくPlant Engineering計画立案、設計、施工 カーボンニュートラルへの取り組み 第一種エネルギー管理指定工場としての省エネ法の対応業務 ユーティリティ設備の運転/監視の委託先の管理業務 工場におけるユーティリティ(電気、蒸気、市水、工業用水等)の供給管理、ユーティリティ設備の管理業務 グローバルネットワークの中の1工場として、上記業務を推進していくとともに、ハンズオンで改善・改革をリードしていくマインドやスキルが求められます。
- 900万〜1300万
- 大阪府
- 医薬品メーカー(先発医薬品)
募集中