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Talent Acquisition Partner · 羅氏中國

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職位介紹: 在羅氏，我們鼓勵每位同事展現真實的自己；我們欣賞獨特且出眾的品質。羅氏的文化鼓勵積極的表達、開放的對話和真誠的連結，在這里，你將因為做自己而被重視、接納和尊重，并得到個人的提升和職業的發展。所有的這一切，都是為了更好地預防、阻止和治愈疾病，并確保醫療資源的可及性和可持續性。歡迎加入羅氏，一個重視每種聲音的地方。職位 Engineering Project Support and Operation Readiness: ● Act as the Facility & Utility Engineer representative on the project team, contributing to design, construction, and qualification activities. This includes reviewing URS (User Requirement Specification), and executing FAT, SAT, and IOPQ to contribute to project delivery. ● Lead or act as facility and utility maintenance team coordinating with Engineering department, production department, quality department, vendors, etc for cooperation to achieve the positive goal. ● Establish and develop facility and utility maintenance operation system in alignment with the Roche standards including maintenance management system, people training and qualification, CCS strategy and implementation to support robust operation readiness. ● Support manager to develop a competent team through coaching, mentoring and training by having in place a skill competencies development and appraisal program to strengthen the technical expertise and capabilities. ● Participate in tech transfer, collaboration with other functions to ensure the success of new product manufacturing. ● Represents the facility and utility during regulatory inspections and audits and participates in the response of regulator audit and global quality audit. Routine Operation & Maintenance: ● System Ownership: ● Take full accountability for the operation and maintenance of Facility & Utility systems, ensuring all activities comply with Roche’s GMP/EHS standards and regulatory guidelines. ● Work as a Sterilization aseptic expert to provide technical support in Facility & Utility aspects. ● On call for system emergent complex trouble shooting escalated from technicians. ● Ensure that all relevant information relating to activities within your scope is tracked, captured and forwarded in due time to your manager or the head of department. ● Establish and maintain a strategic and technical roadmap for the responsible area to support the site's strategic development and product lifecycle. ● Maintenance Execution: ● Plan and execute preventive and corrective maintenance programs to maximize equipment availability and optimize life-cycle costs. ● Enhance Facility & Utility system maintenance and operation through implementation of an effective maintenance and operation program, work prioritization, complying with operational and personnel standards, regulatory and statutory requirement to ensure efficient, reliable, and uninterrupted plant operation. ● Propose spare parts for responsible equipment and control the cost within budget. ● Compliance: ● Ensure audit readiness by adhering to cGMP, regulatory, and statutory requirements to protect product quality and prevent compliance observations. ● Represent the Facility & Utility systems during regulatory inspections and audits. ● Responsible for the Quality and Accuracy of data and records of relevant equipment and maintenance. ● Troubleshooting & Improvement: ● Respond to critical alarms, lead deviation investigations, execute CAPAs, PE and provide timely technical support for complex issues. ● Drive continuous improvement initiatives to enhance sustainability, safety, and asset reliability. ● Ensure in time response to critical alarms in compliance with the SOP and related Quality Procedures. ● Evaluate the alarm trends and establish corrective actions to avoid repeat events. ● Assets Lifecycle Management & Reliability: ● Evaluate the system capacity and provide related Operational & Maintenance data for project initiation. ● As the Facility & Utility system owner and SME, actively participate in the design, review, comment, commissioning and handover of site new projects according to Site CAPEX process. ● Responsible for the implementation of the site Reliability Engineering process within owned areas. ● Sustainability: Support to drive continuous improvement by providing recommendations and initiative to promote sustainability (Energy & Water), safety, maximizing asset reliability and operational performance to drive operation excellence in utilities operation to achieve financial objectives to gain cost competitiveness. ● Documentation: Maintain accurate and timely records of all equipment and maintenance data. Draft and/or review SOPs and other relevant documentation. Qualification and Experience Education/Qualifications ● Bachelor’s degree or above in HVAC, Mechanical-Electronic Engineering, Mechanical Engineering, Chemical Engineering or a related field. ● Familiarity with relevant local regulations and authorities (e.g., NMPA). ● Special Equipment management certification is a plus. Job Required Competencies ● Experience: Minimum 8 years of facility and utility management or engineering experience within the injection pharmaceutical industry, MNC Bio-pharma preferred, with a strong preference for experience in a GMP environment. ● Expertise: ● HVAC (Heating, Ventilation, and Air Conditioning), Clean Utilities (PW, WFI, CS, PA), Electrical Systems, Automation & Controls (BMS, EMS, SCADA, PLC), Wastewater Treatment (WWTP) ● Project Expertise: Proven experience in strategic projects for Aseptic Filling facilities, including design, commissioning, and qualification. ● Startup Experience: Experienced in new facility startup readiness and operation ramp-up. ● Communication: Fluent in written and spoken English, with strong collaboration skills to effectively work with diverse teams and stakeholders. ● Strategy Thinking: Able to think strategically and translate strategies into actionable plans, understand and apply agile ways of working Preferred Qualifications (Nice to Have) ● Experience with BMS/BAS (Building Management/Automation Systems) and related software. ● Experience with Lean Manufacturing or Six Sigma methodologies. ● PMP or other project management certifications. 我們是誰打造更健康的未來是促使我們創新的動力。全球超過100,000名員工共同致力于推進科學，確保今天和明天的人們，都能獲得高質量的醫療資源。我們的努力幫助了2600多萬人使用我們的藥物進行治療，我們的診斷產品運行超過300億次檢測。羅氏通過賦能探索新的可能、激發創造力并保持高標準以提供突破傳統的醫療解決方案，對全球的醫療環境帶去推動和影響。讓我們一起，構建更健康的未來。羅氏提供平等的職業發展機會。

其他信息: 行業要求：生物技術

公司簡介

羅氏成立于1896年，總部位于瑞士巴塞爾，擁有125余年悠久歷史。羅氏致力于不斷探索從前沿科學到疾病診斷和治療藥物的成果轉化，挽救生命、改善人類生活質量，在抗腫瘤、免疫、抗感染、眼科和神經科學領域擁有差異化藥物。作為個體化醫療的倡導者，羅氏不遺余力地推進醫療健康發展，以期創造更大價值。憑借制藥和診斷兩大領域的獨特優勢，結合臨床實踐中的數據洞察，羅氏積極攜手合作伙伴，致力于為每位患者提供合適的治療方案。羅氏總部位于瑞士巴塞爾，業務遍及全球150多個國家。羅氏連續15年位列道瓊斯指數（DJSI）制藥、生物技術和生命科學領域可持續發展的全球先行者之一。這是對羅氏攜手全球合作伙伴，為提升醫療健康可及性長期貢獻的高度認可。美國基因泰克公司（Genentech）是羅氏集團的全資子公司。此外，羅氏也是日本中外制藥株式會社（Chugai）的控股方。更多關于羅氏集團的信息，請登陸羅氏全球網站 www.roche.com。

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公司信息

羅氏中國

關注

企業行業：制藥

人數規模： 5000-10000人

職位地址：上海-浦東新區上海羅氏制藥有限公司(龍東大道)

注冊資本： 201877.03萬人民幣

經營范圍：許可項目：藥品生產；藥品委托生產。（依法須經批準的項目，經相關部門批準后方可開展經營活動，具體經營項目以相關部門批準文件或許可證件為準）一般項目：銷售自產產品；藥物臨床試驗服務；生產線管理服務；企業管理咨詢；企業管理；市場營銷策劃；信息技術咨詢服務；財務咨詢；健康咨詢服務（不含診療服務）；信息咨詢服務（不含法律咨詢、金融信息服務、市場調查、社會調查及其他許可類信息咨詢服務）；醫學研究和試驗發展；普通貨物倉儲服務（不含危險化學品等需許可審批的項目）；從事醫藥科技領域的（人體干細胞、基因診斷與治療技術開發和應用除外）技術服務、技術開發、技術咨詢、技術交流、技術轉讓、技術推廣；非居住房地產租賃；貨物進出口；技術進出口。（除依法須經批準的項目外，憑營業執照依法自主開展經營活動）

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