Nantong QC 设备&LIMS高级工程师 JS 226000

Job description

About the Role: At BioNTech, we are driven by the mission to harness the power of science and technology to improve lives. As a QC LIMS & Equipment Senior Engineer , you will be responsible for implementing, managing, maintaining, and continuously improving our Laboratory Information Management System (LIMS), laboratory analytical instruments, and related digital platforms within the QC laboratory. Your work ensures compliance with GMP standards, data integrity requirements, and business needs—directly contributing to the success of our innovative therapies. You will collaborate with cross-functional teams including IT, QA, QC, and international stakeholders to drive digital transformation in laboratory operations. This is an excellent opportunity to work at the forefront of technology and science in a global environment. Your Contribution: Implementing and optimizing LIMS systems : Conduct requirement analysis, select vendors, manage system deployment/configuration, and coordinate with IT, QA, and QC teams for successful system launch Computerized system validation : Lead or support IQ/OQ/PQ activities; draft or review URS (User Requirement Specifications), FRS (Functional Requirement Specifications), risk assessments, test scripts, and validation reports to ensure compliance with GMP standards Workflow optimization : Design and improve electronic lab workflows for sample management, result entry/review/approval processes (including OOS investigations) to enhance operational efficiency Daily LIMS operations : Manage user access control, master data maintenance, audit trail reviews, troubleshooting issues, and workflow configurations System upgrades & change management : Oversee upgrades and changes by assessing impact and executing necessary testing/revalidation activities Technical support & training : Provide technical assistance to QC laboratory users; develop SOPs (Standard Operating Procedures), work instructions, and training materials Equipment management : Maintain equipment records/status tracking; coordinate qualification/requalification/calibration/preventive maintenance activities in compliance with GMP requirements Cross-functional collaboration : Work with IT teams on system integrations involving ERP/CDS/MES platforms; support OOS/OOT investigations as well as deviation/CAPA activities using system data analysis tools A Good Match: Bachelor’s degree or higher in life sciences or engineering (e.g., Chemistry/Biology/Biotechnology/Pharmaceutical Engineering) or equivalent professional experience Proven expertise in LIMS systems implementation/administration; experience with computerized system validation (IQ/OQ/PQ) is highly desirable Strong understanding of GMP regulations (e.g., EU GMP Annex 11/21 CFR Part 11) with demonstrated ability to maintain compliance across digital platforms Familiarity with laboratory equipment lifecycle management including calibration/preventive maintenance activities Excellent problem-solving skills with a proactive approach to identifying risks related to data integrity/system functionality Proficiency in project management tools/software integration processes; prior involvement in global digitalization projects is an advantage Join us at BioNTech to shape the future of healthcare through innovation. Together we can make a difference! 立即申请 » 查找类似职位: Alle Stellen, All Jobs Terms of Use General Terms and Conditions Data Privacy Statement Imprint Cookie Settings © 2024 BioNTech SE. All rights reserved Cookie 许可管理器 当您访问任何网站时，它可能存储或检索浏览器中的信息，大多数为 cookie 形式。我们尊重您的隐私权，因此您可以选择不允许某些类型的 cookie。但是，阻止某些类型的 cookie 可能影响您的网站体验以及我们能够提供的服务。 需要的 Cookie 需要这些 cookie 才能使用此网站，无法将其关闭。 需要的 Cookie 需要的 Cookie 提供者 描述 已启用 SAP as service provider 我们使用以下会话 cookie，使网站正常工作需要所有这些 cookie： "route" 用于会话粘性 "careerSiteCompanyId" 用于将请求发送至正确的数据中心 "JSESSIONID" 在会话期间位于访问者的设备上，以便服务器能够识别访问者 "Load balancer cookie"（实际的 cookie 名称可能不同）阻止访问者从一个实例跳转到另一个实例 需要来自提供者 SAPasserviceprovider 的 cookie，无法将其关闭 功能 Cookie 这些 cookie 可以通过记住您的登录详细信息、优化视频性能或提供有关如何使用网站的信息来在此网站上提供更好的客户体验。您可以随时自由选择接受或拒绝这些 cookie。请注意，如果您不接受这些 cookie，这些第三方提供的某些功能可能受影响。 同意所有 功能 Cookie 功能 Cookie 提供者 描述 已启用 YouTube YouTube 是一项视频共享服务，用户在此可以创建自己的档案，上传视频，以及观看、点赞和评论视频。选择拒绝 YouTube cookie 将无法观看 YouTube 视频或与其交互。 Cookie 政策 隐私政策 条款和条件 同意来自提供者 YouTube 的 cookie