(Senior) Specialist / Associate Manager of Site Operation, Strategy Planning and Operation at BeOne Medicines in Taipei Neihu

Job description

About us BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter). BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description: 本職位隸屬 Cell Therapy 策略規劃與運營部門，核心職責為直接負責場域設施的 Utility & Engineering 功能，以及 Operation Service 中的 Workplace 與 Material Supply 管理。 本職位需與 System Validation、Financial & Procurement、External Collaborations、Regulatory Compliance 等其他功能同事緊密協作，共同確保 Cell Therapy 基地整體營運順暢。 This role is primarily responsible for Utility & Engineering functions of the Cell Therapy site facility, and the Workplace & Material Supply components of Operation Service. The incumbent will collaborate closely with colleagues owning System Validation, Financial & Procurement, External Collaborations, and Regulatory Compliance functions to ensure seamless site operations. A｜Utility & Engineering（設施工程管理） ▶ 直接負責 / Primary Responsibility 此為本職位核心直接負責範疇 / Core primary scope of this role A1｜環境監控 Environmental Monitoring 監控 Cell Therapy 無塵室及場域之環境監控系統（EMS），包含溫度、濕度、差壓、微粒及微生物監控。 Monitor the Environmental Monitoring System (EMS) covering temperature, humidity, differential pressure, particle count, and microbial monitoring for cleanrooms and site areas. 對異常或超標事件（excursion）即時應對，啟動偏差流程並記錄。 Respond promptly to abnormalities or excursion events; initiate deviation processes and maintain complete records. 定期彙整環境監控趨勢報告，提報管理層。 Compile periodic environmental monitoring trend reports and present to management. A2｜預防性保養 Preventive Maintenance 制定並執行場域設施、公用設備（HVAC、電力、氣體、液態氮系統等）的預防性保養計畫。 Develop and execute preventive maintenance plans for site facilities and utility systems (HVAC, electrical, gas, liquid nitrogen systems, etc.). 管理並追蹤保養記錄，確保校驗與保養文件的完整性與可追溯性。 Manage and track maintenance records, ensuring completeness and traceability of calibration and maintenance documentation. 與設備/設施廠商協調，安排並監督定期保養作業。 Coordinate with equipment/facility vendors to schedule and supervise routine maintenance activities. A3｜系統升級 System Upgrading 評估並規劃設施系統升級需求，協調工程施工與系統切換。 Evaluate and plan facility system upgrade requirements; coordinate engineering works and system changeover. 確保升級過程符合 GMP 要求，並配合 System Validation 同事完成相關資格確認（Qualification）。 Ensure upgrade activities comply with GMP requirements; collaborate with System Validation colleagues to complete relevant qualification activities. 追蹤升級專案進度，並向管理層彙報里程碑達成狀況。 Track upgrade project progress and report milestone achievements to management. A4｜故障排除 Troubleshooting 作為場域設施問題的第一線應對窗口，及時診斷並協調解決設備或公用系統故障。 Serve as the first point of contact for site facility issues; promptly diagnose and coordinate resolution of equipment or utility system failures. 管理偏差事件（Deviation），執行根本原因分析（RCA）及矯正預防措施（CAPA）。 Manage deviation events; conduct root cause analysis (RCA) and corrective/preventive actions (CAPA). 建立故障排除知識庫，持續優化應對流程。 Build a troubleshooting knowledge base and continuously improve response processes. A5｜新設備安裝 New Installation 協調