杭州招聘

Talent@Boehringer Ingelheim

About Biopharmaceutical Contract Manufacturing

Boehringer Ingelheim aims to become China’s first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China’s biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China’s innovative medicines in a bid to accelerate growth of China’s bio-technology industry. The Company’s state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets. 

Job Responsibilities

1. Manage Calibration Program for BioChina. Evaluate calibration requirements for new and existing equipments / systems, based on cGMP, and National / international regulatory Pharmacopoeia requirements. Coordinate/supervise/manage the calibration activities for GMP process critical equipment / system，and ensure good management of calibration laboratory and its calibration tools, in order to deliver high quality calibration services.

管理BioChina的校准程序。根据cGMP,国家/国际药典要求评估新设备和现有设备/系统的校准要求。协调/监督/管理GMP关键设备/系统的校准工作，确保校准实验室及其校准工具的良好管理，提供高质量的校准服务。

 

2. Provide professional technical knowledge on calibration, to support operation and maintenance activities. Acting as calibration lead Engineer, create and implement local SOP's, test methods, and GxP processes, in conjunction with Global calibration management procedures and processes.

 Take ownership for Calibration related change controls, improvement initiatives, Deviations, Investigations, CAPA's etc, to ensure safe, compliant, cost effective, reliable and efficiently optimized Calibrations.

提供专业的校准技术知识，支持操作和维护活动。作为校准首席工程师,创建和实现当地SOP,测试方法,和GxP过程,结合全球校准管理程序和流程。

  负责校准相关的变更控制、改进措施、偏差、调查、CAPA等，确保安全、合规、成本有效、可靠和高效地优化校准。

 

3. Lead the internal/external teams to manage the calibration master plan. Manage external service team to ensure strict calibration execution according to schedule.

领导内部与外部团队管理校准主计划，管理外部服务供应商团队从而确保校验严格按照计划实施;

 

4.Continuously improves necessary technical knowledge to ensure the above three main purposes to be continuously fulfilled.

不断提高必要的技术知识以确保以上三项主要目标持续完成。

 

5.MP Compliance & EHS GMP合规与环境/健康/安全

- Ensure the system/equipment/Instruments follow the appropriate calibration, based on National regulation, including the special equipment related to safety.

确保系统/设备/仪表根据国家法规进行校验。包含与安全有关的特种设备。

- Ensure correct and responsible behavior in accordance with compliance and EHS, complete the training on time.

确保日常工作行为符合公司合规与EHS的要求，按时完成相应的培训

- Perform routine equipment safety inspection and machinery optimization during site survey.

 在日常巡检工作中，执行现场设备安全的检查并进行优化

- Recommends technical solutions for improving EHS and realize the recommendations after approval as required.

提出EHS安全建议并根据需要完成相关的安全整改项

- Support the accident/incident reporting and investigation

协调事故/事件的报告和调查

 

6.Operation 运营

- Management and control of the annual master calibration program and Calibration plan for BioChina. Manage Calibrations for cGMP Process Critical systems/equipments/Instruments across 2 sites.

 制定并管理年度主校准程序与校准主计划。管理两个厂区cGMP相关的关键工艺系统/设备/仪表的校准。

- Lead and control the calibration lifecycle process, performing periodic reviews, analytical trending, performance assessments to ensure reliable, controlled and compliant manufacturing processes.

 领导和管理校准的整个生命周期过程，执行定期评审，趋势分析，性能评估，以确保可靠的，受控的，合规的生产过程。

- Daily coordination / integration of work scheduling activities aloneside maintenance, validation and production activities; assign personnel to perform tasks, based on pre-aligned schedules.

Manage daily coordination of internal/external service suppliers to effectively perform tasks in time, budget and Quality. Supervise work activities and be accountable for results.

日常协调/整合工作安排活动满足维护、验证和生产活动;根据预先达成一致的计划安排执行任务的人员。

  管理内部/外部服务供应商的日常协调工作，确保按时、按质、按量地完成任务。监督工作活动并对结果负责。

- Responsible for the creation and management of all necessary Calibration related SOP's, methods etc. in accordance to local and international Industry standards, and compliant with Technical and regulatory authorities. Ensure availability and standardization of necessary tools, test instruments, and materials for all calibration work. Responsible for the day to day running of the Calibration Laboratory.

负责根据本地和国际行业标准建立和管理所有必要的校准相关SOP、方法等，并确保符合技术和监管机构的要求。确保所有校准工作所需的工具、测试仪器和材料的可用性和标准化。负责校准实验室的日常运行。

- Make provisions for appropriate Calibration related training of all involved personnel. Act as SME for all Calibration technicians for BioChina.

作为BioChina所有校准的系统负责人。对所有相关人员进行相应的校准培训。

Perform / support technical Calibration activities as required, including HEPA certification programs.

根据需要执行/支持技术校准活动，包括HEPA认证项目。

- Manage calibration related systems and their information master data  i.e. SAP GBS, BIgCal. Ensure systems remain continuously updated to a high Quality standard, and reflect the operational status of the Equipments / Instruments in the manufacturing field.

  管理校准相关系统及其信息主数据，如SAP GBS、BIgCal。确保系统持续更新以满足高质量标准，并反映生产设备/仪器的运行状态。

-Oversee Calibration related Cost Center Budget as needed. Develop concepts / implement measures to keep the OpEx cost in calibration to a minimum, whilst appropriately planning CapEx requirements in consideration to asset lifecycle management.

  负责校准所需的相关成本中心预算。改进/实施措施，将校准中的运营成本降到最低，同时考虑资产生命周期管理，合理规划资本支出需求。

 

7.Project related 项目相关

- According to company and department strategy, as well as end user's requirement, manage calibration related process equipment project activities and improvement Initiatives.

根据公司战略和最终用户需求，适时开展工艺设备相关的校验项目优化

- Ensures availability and operational readiness of equipment and systems, in compliance to all relevant GMP and EHS regulation. Performs / Leads Equipment, Instrument criticality assessments as part of qualification support and GMP readiness.

确保设备和系统的可用性和运营准备状态,并且必须遵守GMP和EHS相关法律法规

- Supports / coordinates engineering partners on calibration related process topics, typically during process design phase

在校准方面领导和协调各方合作伙伴

- Coordinates procurement, design, installation, commissioning, documentation activities of equipments and systems

协调采购，设计，安装，设备和系统调试活动

- Provides financial overview and controlling of project / initiative scope over entire lifetime

在项目期间提供财务概况和支持财务控制

 

8.MP&Quality 质量

- Responsible for the effective execution of Change Controls, Deviations, Investigation, CAPAs Etc. relating to Calibration hardware and process.

负责与校准有关的变更，偏差，调查和纠正/预防措施等硬件和流程的有效执行。

- Be responsible for GMP-compliant documentation related to calibration. Ensure Good Document Practice (GDP), robust Data Integrity (systems, processes & documentation). Ensure all Calibration program related activities comply with local/global BI & Authority/Regulatory procedures, Methods, Standards etc. 

负责校验相关的GMP合规性文件。确保良好的文件使用。确保所有校准程序遵守BI本地/全球以及权威机构和法规的程序，方法，标准等。

- Execute / complete calibration work on time and quality according to the master plan.

根据主计划，保证时间和质量完成校准工作

- Supervise / Authorize / Certify the calibration work performed by 3rd party with high quality

监督第三方高质量地完成校准工作

- Takes lead role in Customer & Regulatory audits, in topics relating to the calibration Management Program for BioChina, and takes ownership of any subsequent observations.

在与BioChina校准管理相关的客户和监管审计中发挥领导作用，并对后续的任何审计发现结果负责。

 

9.Compliance to Global and Local SOP's, GMP / Regulatory requirements & Environment (cGMP, FDA, CFDA, EMA, etc) and Local Legal legislation.

Compliance to CSV & C Regulations for computer systems

遵守全球和当地SOP, GMP /法规要求和环境(cGMP, FDA, CFDA, EMA等)和当地法律法规。

遵守CSV & C计算机系统法规

 

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