(Senior) Specialist / Associate Manager of Site Operation, Strategy Planning and Operation

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.

▶ 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

• 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.

• 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.

• 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.

• 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.

• 協調新設備或設施系統的安裝作業，包含場地評估、廠商溝通及安裝驗收。
• Coordinate new equipment or facility system installation, including site assessment, vendor communication, and installation acceptance.
• 配合 System Validation 同事，確保新裝設備完成適當資格確認（IQ/OQ/PQ）。
• Work with System Validation colleagues to ensure newly installed equipment completes appropriate qualification (IQ/OQ/PQ).
• 更新設備清單及相關保養校驗計畫。
• Update equipment inventory and related maintenance/calibration plans.

B

▶ 直接負責 / Primary Responsibility  此為本職位於 Operation Service 中直接負責之兩項子功能 / Primary sub-functions within Operation Service

• 維護 Cell Therapy 實驗室及辦公空間的日常運作，確保工作環境整潔、安全且符合法規要求。
• Maintain day-to-day operations of Cell Therapy lab and office spaces, ensuring a clean, safe, and compliant working environment.
• 管理場域清潔、廢棄物處置、病蟲害防治等支援廠商，監督廠商執行品質。
• Manage supportive vendors for site cleaning, waste disposal, pest control, etc.; monitor vendor service quality.
• 協同 WPS，擔任 BeOne Medicines Cell Therapy 與大樓管理辦公室之對接窗口，處理場域相關事務。
• Collaborate with WPS as the contact point between BeOne Medicines Cell Therapy and the building management office for site-related matters.
• 管理實驗室進入更衣物料（gowning materials），確保供應穩定。
• Manage lab gowning materials to ensure consistent availability.
• 協助規劃及執行場域行政事務，包含空間分配及設備使用預約協調。
• Support site administrative activities, including space allocation and equipment usage scheduling.

• 負責無塵室物料的入庫收料、庫存追蹤及室溫物料的日常管理。
• Manage goods reception, inventory tracking, and daily management of room-temperature materials for the cleanroom.
• 確保耗材、試劑及實驗室一般用品的系統性訂購與補充，維持穩定的供應庫存。
• Ensure systematic ordering and replenishment of consumables, reagents, and general lab supplies to maintain stable inventory levels.
• 建立並維護物料庫存管理系統，定期盤點與核對庫存數據。
• Establish and maintain a material inventory management system with periodic stocktaking and data reconciliation.
• 提供採購端到端支援，包含 PR/PO 申請及 Invoice 處理，及時回應研究人員的需求。
• Provide end-to-end procurement support including PR/PO requests and invoicing, responding to researchers' needs in a timely manner.
• 管理物料進出口申請及物流協調，確保流程順暢不影響研究作業。
• Manage material import/export applications and logistics coordination to ensure smooth operations without impacting research activities.
• 協調物料出貨至外部委託製造廠的相關作業。
• Coordinate material shipment logistics to the external manufacturing site.

↔ 跨功能協作 / Cross-functional Collaboration  以下功能由其他同事主責，本職位負責配合協作 / The following are owned by other team members; this role contributes as a collaborator

• 與 System Validation 同事協作，配合設備/設施資格確認活動（IQ/OQ/PQ）及文件準備。
• Collaborate with System Validation colleagues to support equipment/facility qualification activities and documentation.
• 與負責 Financial Analysis、Procurement & Sourcing、Vendors & Suppliers 的同事協作，提供場域物料需求資訊及供應商執行狀況回饋。
• Work with colleagues managing Financial Analysis, Procurement & Sourcing, and Vendors & Suppliers by providing site material requirements and vendor performance feedback.
• 與負責 External Collaborations 的同事協作，支援外部委託製造廠相關物料及設施需求的協調。
• Collaborate with the External Collaborations owner to support coordination of material and facility needs related to the external manufacturing site.
• 與負責 Regulatory Compliance、Document Submission & Archival 的同事協作，確保場域相關文件符合法規要求並妥善存檔。
• Work with Regulatory Compliance and Document Submission & Archival colleagues to ensure site-related documents meet regulatory requirements and are properly archived.
• 協助內部或外部稽查（Audit）活動，提供 Utility & Engineering 及 Workplace/Material Supply 範疇之相關文件與記錄。
• Support internal or external audit activities by providing relevant documentation and records within the Utility & Engineering and Workplace/Material Supply scope.

Qualification Required:

• 生命科學、生物技術、生物醫學工程、機械/電機工程、化學或相關領域學士以上學歷。
• Bachelor's degree or above in Life Sciences, Biotechnology, Biomedical Engineering, Mechanical/Electrical Engineering, Chemistry, or related field.

• 具備 1 年以上實驗室設施管理、工程維護或相關領域工作經驗。
• At least 1 year of experience in laboratory facility management, engineering maintenance, or related field.
• 應徵資深專員或副理職等者，歡迎具備更豐富的設施管理、廠商協調或跨部門專案經驗之人才。
• Candidates with more extensive experience in facility management, vendor coordination, or cross-functional project management are welcome to apply for the Sr. Specialist or Associate Manager level.

• 具備設施系統（HVAC、氣體系統、電力、液態氮）操作及基本故障排除能力。
• Knowledge of facility utility systems (HVAC, gas systems, electrical, liquid nitrogen) with basic troubleshooting capability.
• 熟悉 GMP 環境監控要求及無塵室操作規範。
• Familiarity with GMP environmental monitoring requirements and cleanroom operational standards.
• 具備物料管理、庫存管控及採購流程（PR/PO/Invoice）實務經驗。
• Practical experience in material management, inventory control, and procurement processes (PR/PO/Invoicing).
• 具備偏差管理及 CAPA 撰寫經驗。
• Experience in deviation management and CAPA documentation.
• 設備資格確認（IQ/OQ/PQ）相關背景為加分條件。
• Experience with equipment qualification (IQ/OQ/PQ) is a plus.
• 細胞治療或生物製藥相關背景者優先考慮。
• Background in cell therapy or biopharmaceuticals is preferred.

• 中文流利（必要）；英文具備閱讀、書寫及溝通能力（必要）。
• Fluent Chinese (required); English reading, writing, and communication proficiency (required).
• 熟悉 Microsoft Office（Word、Excel、PowerPoint）及環境監控系統（EMS）。
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and Environmental Monitoring Systems (EMS).
• 具備 ERP 或電子採購系統操作經驗者佳。
• Experience with ERP or e-procurement systems is a plus.

四、核心工作職能摘要 / Essential Functions Summary

• 場域設施 Utility & Engineering 管理（環境監控、預防性保養、系統升級、故障排除、新設備安裝）
• Site facility Utility & Engineering management (environmental monitoring, preventive maintenance, system upgrading, troubleshooting, new installation)
• Workplace 工作場域運營管理 / Workplace operation management
• Material Supply 物料供應與庫存管理 / Material supply and inventory management
• 跨功能協作（System Validation、Finance、Procurement、Regulatory Compliance 等） / Cross-functional collaboration
• Cell Therapy 文件存檔與記錄維護 / Cell Therapy documentation and record keeping

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme

• Company shares (generous welcome grant!)

• In-house and external learning and development opportunities

• Fantastic benefits program and keep improving!

• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

• Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.