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. |
企業情報
匿名
関連する求人
ACCOUNTABILITIES: Working closely with the Head of GIRM and other team members, participate in further developing a high-quality global insurance & risk management function considering all insurance and operational risk management needs of a global company. Participate in and lead insurance projects and assigned insurance programs (such as Directors and Officers Insurance) Support independently local Japanese subsidiaries in insurance related queries according to Global Insurance Guidelines Develop and maintain sound insurance reporting procedures and systems for collection and maintenance of underwriting information needed for e.g. renewal of local/ global insurances Responsible for assigned global insurance programs dealing with complex negotiations with (international) insurance companies and brokers on terms and conditions Take part in defining the scope of work for the insurance brokers who will assist us in order to acquire the most optimal insurance solutions for global insurance programs Maintaining relationships with insurance brokers (particularly those situated in Japan), industry consultants to develop, implement, maintain and update insurance risk management policies, procedures and programs to meet the company's changing environment. Support the global business on contractual risk management reviews and determine appropriate types and level of insurance. Responsible for the identification and assessment of risks to property, personnel, and ongoing business activities in general. Responsible for collection and review of critical underwriting data and preparation of insurance submissions for the assigned global insurance lines and participate in renewal negotiations. Prepare documentation on the assigned insurance lines for decision making on renewal activities by Senior Management Responsible for reviewing the assigned insurance policies for accuracy, recommending appropriate loss retention levels (deductibles, self-insurance levels, etc.) and negotiating insurance coverages, provisions, and premiums in the insurance markets. Support and work closely with other departments in the development and implementation of risk management actions relevant for the insurance lines mentioned Oversee the proper handling and settlement of claims for the assigned insurance lines Support GIRM colleagues with their assigned insurance lines per request Maintain Japan LOC network relationship. Participate in Risk Engineering especially for local sites. Responsible for local CAPEX stand-alone project insurances Maintain the relationship with Japan’s partner insurance agent
- 500万〜1300万
- 東京都
- 医薬品メーカー(先発医薬品)
募集中
- 工場基幹ユーティリティ設備の基本計画、技術検討、将来計画を立案すると共に、工事実施に際して設計、取引先への製作指示、コミッショニングを行うことで設備導入を図る。 - 上記の生産設備を設置する建物ならびに建物設備の企画、立案、設計、取引先への製作指示、コミッショニング、クオリフィケーションを行い、建設プロジェクトを実施する。 - ステークホルダから要件をヒアリングの上で生産設備、用役設備のフィージビリティスタディ、コンセプトデザインの検討を行い、設備計画を取りまとめる。 - 生産設備や用役設備の中長期的な計画を策定・管理を行うことでサイト戦略を立案する。 - 品質保証に関する業務を理解して必要なドキュメントの作成、レビューを行う。
- 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】 医薬品製造設備や工場建屋の新設工事ならびに改良工事における、クオリフィケーション業務を担当します。 担当工事のクオリフィケーション責任者として、医薬品製造設備、重要なシステム(ユーティリティ)や施設を検査し、適切な仕様を満たしているかを評価します。 ・以下の主な業務に従事いただきます。 プロトコール作成 クオリフィケーション作業の調整 クオリフィケーションの実施 クオリフィケーション報告書の作成 上記業務を実行するにあたり、製造部門、エンジニアリング部門、品質管理部門が日々連携して業務を行います。
- 500万〜1300万
- 山口県
- 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