医薬品メーカー（先発医薬品）

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.

【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。

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.

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary ・Responsible for activities related to study start up（SSU) and ongoing study document management ・Act as point of contact for local study teams and external stakeholders Key Responsibilities ・Independently manages multiple country, study and site level deliverables during start-up and maintenance both within internal and external business partners and vendors, when required. ・Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial　milestones. ・Ensure Investigator Sites are eligible to conduct clinical trials, through the review and approval of essential clinical trial and regulatory documents. ・Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission. ・Prepare and perform submissions for Ethics Committees/IRB including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). ・Collaborates with other internal roles in country feasibility and site selection. ・Collaborates directly with the internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines. ・Prepare country Informed Consent Form (ICF) and manage country ICF template. ・Review and approval of Site ICFs ・Complete Clinical Trial Package (CTP) documentation. ・Update national registries as applicable. ・Ensures that the electronic Trial Master File 　(eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site 　activation and ongoing study management. ・When applicable, conduct drug/IMP label review & translation. ・Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and Legal. ・May support the collection and distribution of documents from/to sites including obtaining insurance certificates. ・May support Health Authority inspection and pre-inspection activities. ・May support audit preparation & Corrective Action / Preventative Action preparation for local related issues.