Project Controls Engineer(Associate Director), Japan New Plasma Facility Project
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勤務地大阪府
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職種その他製剤化/製造・生産関連職
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業種医薬品メーカー（先発医薬品）
募集要項
| 業務内容 |
OVERVIEW Project Controls Engineer Are you ready to take on complex challenges while building your career? Are you interested in helping ensure that projects operate at the highest quality, within a Site Engineering team that manufactures life-saving treatments for patients? Join us as a Project Controls Engineer in Osaka Plant. Every day, Engineers at changing lives, impacting millions, and shaping the future of healthcare. On our Site Engineering team, you will be empowered to implement comprehensive project cost and schedule planning, control processes, and manage risk in support of successful project delivery. You will have the authority to make choices that contribute to our greater purpose of improving people's lives while protecting our planet. Supported by talented and respectful colleagues, you will be offered stimulating experiences that enhance ongoing career opportunities. ENGINEER YOUR FUTURE ● Develop and manage comprehensive Basis of Schedule and Cost Estimate and integrate construction planning efforts. ● Develop manageable cost and schedule packages for use by the project team. ● Ensure schedule has complete scope coverage, procurement milestones are considered, critical path defined, and potential scope growth identified. Utilize industry and internal benchmarks to validate the quality of the overall schedule. ● Analyze cost performance, maintain the monthly cash flow forecast, and ensure control of budget and spend using an approved project change request process, including allowances and contingency. ● Monitor resource plan and periodically perform Earned Value Analysis where applicable. ● Work with key stakeholders to identify cost and schedule risks and apply quantitative risk analysis methods (e.g., Monte Carlo Simulation) where applicable. ● Develop and deploy appropriate project change management processes and risk mitigation procedures. ● Develop and prepare monthly cost and schedule reports based on project definition and execution phase. ● Lead subcontractors invoice management. Track the budget, expenditures, and Estimate At Completion. ● Assist procurement during the bidding process and tendering period by assessing proposed cost against budget. ● Ensure purchase requests are based on initial budgeted scope (or approved scope changes), place and approve Purchase Requests in Ariba, and monitor the purchase process. ● Liaise with site finance departments to ensure accruals and further reconciliations are updated. |
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| 雇用形態 | 正社員 |
| 応募資格 |
WHAT YOU’LL BRING Required Qualifications: ● Education: Bachelor’s degree in Engineering, Science, or Financial field ● 5+ years of relevant experience in cost planning, scheduling; preferably in Biotech, Pharmaceutical or other regulated industry (good GMP knowledge preferred) ● Skilled in project scheduling and cost control EVERYONE AT A LEADER All of our employees, at all levels, are leaders who embody our leadership behaviors and live the values that guide the organization. Here are a few of the ways the Project Controls Engineer will live these leadership behaviors every day: ● Think Strategically: Demonstrates innovation and creativity to analyze and solve complex problems through innovative thought and experience ● Inspire Others: Operates collaboratively and influences across the organization ● Deliver Priorities: Translates innovation initiatives into project design and execution ● Elevate Capabilities: Proactively takes steps to learn and grow ● Experience with risk management, and reporting on large capital projects ● Familiar with benchmarking in the pharmaceutical industry ● Advanced knowledge of MS Excel and scheduling software ● Good problem-solving skills ● Strong communication skills WHAT CAN OFFER YOU ● Opportunities to learn and build your career in a global, fast-paced environment ● A global workplace where you’ll work with colleagues from diverse cultures and backgrounds, and where your unique perspective and experiences will be valued ABOUT ENGINEERING Engineering accelerates mission by delivering innovative solutions that shape the future of healthcare and change lives for the better. globally recognized ISPE (International Society for Pharmaceutical Engineering) awarded leader, you will imagine new possibilities, solve complex problems with cutting-edge technologies, and grow a career that matters to millions. Learnmore about engineering |
| 英語力 | ビジネスレベル |
| 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 賃金はあくまでも目安の金額であり、選考を通じて上下する可能性があります。 月給(月額)は固定手当を含めた表記です。 |
| 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. |
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関連する求人
職務内容 製造設備の導入、建設プロジェクトにおけるプロセス（生産・製造）機械の設計業務（詳細設計・予算算出・実行管理・試運転・引き渡し) 生産、研究、管理設備に関するユーザー部門への技術的サポート（導入、更新、改善） GMPに関する技術情報管理、新技術評価
- 900万〜1300万
- 千葉県
- 医薬品メーカー（先発医薬品）
募集中
職務内容 １．グローバルチーム及びサイトチームと連携し、電子バリデーションシステム（Kneat）の日々の運用・保守と継続的な改善を推進する。また、マイナーなソフトウェア変更作業、変更管理の作成、レビュー、および承認を行う。 ２．サイトおよびグローバル・プロジェクトに、エンジニアリング・コンプライアンスと電子バリデーションシステムにおける広範な知識とリーダーシップを提供する。 このポジションは、エンジニアリング・コンプライアンスに関して下記を保証する。 ・関連法規制要件、業界標準及び社内基準に対するコンプライアンス ・バリデーション活動に対する査察準備と実行 ・バリデーション担当者のトレーニング ・エンジニアリングサービス関連の活動に関連するRCA（Root Cause Analysis）/CAPA（Corrective Action & Preventive Action）のサポート ・バリデーションドキュメント管理のサポート ・品質/バリデーションカウンシルで提示される指標管理（バリデーションメンテナンスなど） 仕事のやりがい ・GMP環境下で実施するバリデーション文書作成、承認及び保管、並びにデータを記録するための標準ソフトウェアである電子バリデーションシステム（Kneat）のスキル、また深い知識及び経験を獲得できる。 ・獲得した電子バリデーションシステム（Kneat）の知識、経験を活かして、バリデーション活動で活躍することができる。 ・バリデーションに関連したコンプライアンス活動をリードすることで、成田工場及びGMP及びコンプライアンスの向上に貢献できる。
- 500万〜800万
- 千葉県
- 医薬品メーカー（先発医薬品）
募集中
【職務内容】 工場において、医薬品の品質管理及び品質保証業務における以下業務を担うリードもしくは担当者です。 ・ショップフロアQA（現場作業を直接監視・監督） ・バッチレコードを含む書類の照査 ・逸脱調査 ・出荷判定 ・バリデーション ・変更管理 ・試験記録のレビュー など 業務範囲は、光工場の生産部門及び試験部門であり、対象製品は原薬／固形製剤、麻薬製剤などがありますので、適性と経験を考慮します。 【キャリアの展望】 この業務を経験されると、国内外の医薬品に関する品質保証業務全般の知識スキルを習得する事が出来ます。また、製薬品質保証室には、原薬、固形製剤、無菌製剤、ワクチンを担当するグループもあり、品質保証室内のローテーションにより幅広い剤型に対する品質保証エキスパートになれる機会が得られます。
- 500万〜1300万
- 山口県
- 医薬品メーカー（先発医薬品）
募集中
OBJECTIVES/PURPOSE Responsible for designing, developing, and maintaining electrical and automation systems. The successful candidate will work closely with cross-functional teams to ensure that all electrical and automation systems are in compliance with regulatory requirements and industry standards. Project engineering for the Strategic Automation Pillars in the areas of: Automation Security & Integrity Engineering Automation & Control Systems Data Integrity Automation Cybersecurity Automation Solutions & Systems Engineering Functional setups & architectures of systems & components Supervisory Control Structures & Data Mgt. Automation Data Engineering Standard Automation Integration Layer (Shopfloor Systems & Data Integration) Data Channels, HMI, displays & Visuals Historization Automation Data Governance Engineering Data Structures & Contextualization Use Case Owner Liaison Mgt, Technical2Business (and vice versa) translation ACCOUNTABILITIES As a member of the Engineering workstream of the project, provides guidance and leadership to all automation-related activities in accordance with the Global Automation Strategy. In detail, He/she will: Report to the engineering manager. Develop and maintain automation guidelines and standards based on project approved budget and schedule, and ensure compliance Ensure that all automation systems meet regulatory requirements, client specifications, and industry standards and define the user requirements. Ensure compliance with Automation Standard Requirement Specification, Automation Engineering Guideline, compliance, and cybersecurity in the project. 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 automation documents and concepts. Conduct gate keeping reviews. Review and approve contractor submittals.
- 500万〜800万
- 大阪府
- 医薬品メーカー（先発医薬品）
募集中