MES顾问（生命科学行业/全国范围都可投递支持线上办公）

该职位来源于猎聘 一、职位概述 / Role Overview 我们正在寻找一名MES顾问，为生命科学领域客户提供制造执行系统（MES）咨询与交付服务。该岗位需要能够连接业务与技术团队，将生产运营需求转化为健壮的系统解决方案。候选人应具备较强的业务分析和项目管理能力，能够独立推进需求调研、流程设计及关键交付活动；同时具备一定的开发和技术问题分析能力，并能够使用英语开展日常工作及跨国项目协作。 We are seeking a MES Consultant providing MES consulting and delivery services to life sciences clients. This role connects business and technical teams, translating manufacturing needs into robust system solutions. The successful candidate will bring strong business analysis and project management capabilities, independently drive requirements discovery, process design, and key delivery activities, and contribute to development and technical troubleshooting.

The ability to work effectively in English within international project teams is essential. 二、主要职责 / Key Responsibilities 1. 业务分析与解决方案设计 / Business Analysis &

• Solution Design 主导需求访谈与工作坊，识别生产运营、质量、供应链及IT团队的业务需求，明确项目范围、业务优先级和验收标准。 Lead requirements interviews and workshops with manufacturing operation, quality, supply chain and IT stakeholders to define scope, business priorities, and acceptance criteria. 梳理现状与目标业务流程开展差距分析，提出兼顾业务价值、系统标准能力和GMP合规要求的解决方案。 Map As-Is and To-Be processes, conduct gap assessments, and propose solutions that balance business value, standard system capabilities, and GMP compliance. 编写并维护功能规格说明书、配置说明书、设计说明书、流程图、验证方案等交付文档；协助其它验证文件准备，如需求说明书、风险分析、需求追溯矩阵。 Develop and maintain deliverables such as Functional Specifications, Configuration specification, Design specification, process maps, Validation Protocols. Coordinate with other validation documents such as URS, RA, RTM. 将业务需求转化为MES配置、电子批记录及接口设计要求，与客户和技术团队共同评估方案可行性及变更影响。 Translate business requirements into MES configuration, electronic batch record, and interface requirements, working with clients and technical teams to assess feasibility and change impact. 2. 项目管理与交付推进 / Project Management &
• Delivery 担任项目经理负责项目交付，制定并跟踪项目计划、里程碑、资源安排及交付成果。 Act as a project manager, responsible for project delivery and establish and track plans, milestones, resource allocation, and deliverables. 管理项目范围、进度、风险、问题及依赖关系，识别交付偏差并推动纠正措施；支持成本跟踪和变更控制。 Manage scope, schedule, risks, issues, and dependencies; identify delivery deviations and drive corrective actions; support cost tracking and change control. 协调客户业务部门、质量部门、IT团队、供应商及全球交付团队，推动关键决策和跨团队问题解决。 Coordinate client key stakeholders to facilitate decisions and resolve cross-team issues. 组织项目状态汇报及阶段评审，协调测试、验证、用户培训、上线切换及上线后支持。 Lead project status reporting and milestone reviews, and coordinate testing, validation, user training, cutover, and post-go-live support.
• MES实施与技术支持 / MES Implementation &
• Technical Contribution 参与MES系统配置、主数据及电子批记录建模，确保系统设计符合生产流程和质量控制要求。 Contribute to MES configuration, master data setup, and electronic batch record modelling to support manufacturing processes and quality controls. 根据项目及平台需要，承担适度的脚本开发、扩展开发、数据处理或接口开发工作，并完成相应的技术文档和测试。 Perform scripting, limited extensions, data processing, or interface development as required by the project and platform, including relevant technical documentation and testing. 参与MES与按照ISA95设计的外围系统的集成设计、联调和故障排查。 Contribute to integration design, testing, and troubleshooting between MES and outside systems aligned with ISA95. 通过日志分析、SQL查询及接口数据检查定位技术问题，与开发团队协作完成缺陷修复和性能优化。 Investigate technical issues through log analysis, SQL queries, and interface data checks, collaborating with developers on defect resolution and performance improvements. 4. 合规与知识共享 / Compliance &
• Knowledge Sharing 在系统设计、开发及交付过程中落实GMP、数据完整性和计算机化系统验证要求，配合客户完成相关验证活动。 Apply GMP, data integrity, and computerized system validation requirements throughout design, development, and delivery, supporting client validation activities. 沉淀项目模板、实施方法和可复用解决方案，指导初级顾问，并根据需要支持售前阶段客户调研、方案编写、POC方案设计及工作量估算。 Develop reusable templates, delivery methods, and solutions; mentor junior consultants; and support presales discovery, proposal development, POC design and effort estimation when required. 三、任职要求 / Required Qualifications 行业与MES经验 / Industry &
• MES Experience 本科及以上学历，计算机、自动化、软件工程、制药工程或相关专业。 Bachelor's degree or above in computer science, automation, software engineering, pharmaceutical engineering, or a related field. 通常具有3年及以上MES或制造数字化相关经验，其中包括制药、生物技术或其他GMP监管环境下的项目经验。 At least 3 years of experience in MES or manufacturing digitalization, including project experience in pharmaceutical, biotechnology, or other GMP-regulated environments. 具有至少两个MES项目从需求分析到上线的完整实施经验。 Proven experience in leading at least 2 full MES implementation lifecycles, from requirements analysis through go-live. 熟悉制药生产核心流程及MES典型应用场景，例如称量配料、物料追踪、电子批记录、设备状态管理、例外审核及批次追溯。 Understand core pharmaceutical manufacturing processes and typical MES use cases, such as dispensing, material tracking, electronic batch records, equipment status management, review by exception, and batch traceability. 业务分析能力 / Business Analysis Capabilities 能够独立主持需求工作坊，识别业务痛点，澄清复杂或冲突需求，并推动利益相关方达成一致。 Able to independently facilitate requirements workshops, identify business problems, clarify complex or conflicting requirements, and build stakeholder alignment. 具备扎实的流程建模、需求文档编写、差距分析和需求变更管理能力。 Demonstrate strong process modelling, requirements documentation, gap analysis, and requirements change management skills. 能够清晰解释业务需求与技术实现之间的关系，并在标准配置、流程调整和定制开发之间提出合理建议。 Clearly explain the relationship between business needs and technical implementation, and recommend appropriate trade-offs among standard configuration, process changes, and custom development. 项目管理能力 / Project Management Capabilities 具有项目经理、子项目经理或工作流负责人的实际经验，能够协调多方资源并对交付结果负责。 Have hands-on experience as a project manager, sub-project manager, or workstream lead, coordinating multiple parties and taking ownership of delivery outcomes. 掌握项目计划、风险与问题管理、范围与变更控制，以及管理层状态汇报方法。 Be proficient in project planning, risk and issue management, scope and change control, and management-level status reporting. 能够在客户现场或跨地域团队环境下推进工作，及时识别和升级影响项目交付的问题。 Be able to drive progress in client-facing and distributed team environments, identifying and escalating delivery issues promptly. 丰富的关键决策人管理经验。 Proven experience in managing key stakeholders. 技术能力 / Technical Capabilities 具备至少一种相关编程或脚本语言的实际使用经验，例如C#/.NET、Java、Python或MES平台专用脚本语言，能够完成二次开发并理解现有代码逻辑。 Have practical experience with at least one relevant programming or scripting language, such as C#/.NET, Java, Python, or an MES-specific scripting language, and be able to deliver secondary development tasks and understand existing code. 熟练使用SQL进行数据查询和问题分析，了解关系型数据库及基本数据建模。 Be proficient in SQL for data queries and troubleshooting, with an understanding of relational databases and basic data modelling. 了解REST/SOAP等接口方式以及JSON/XML等数据格式，具备系统集成或接口调试经验。 Understand integration methods such as REST/SOAP and data formats such as JSON/XML, with experience in system integration or interface troubleshooting. 了解OPC UA/OPC DA/Modbus TCP/RS232/RS485等工业协议，具备工业集成经验。 Understand industrial protocol like OPC UA/OPC DA/Modbus TCP/RS232/RS485, experienced in industrial integration. 合规与语言能力 / Compliance &
• Language Skills 理解GMP、GAMP 5、数据完整性原则，以及21 CFR Part 11和EU GMP Annex 11等与电子记录和计算机化系统相关的要求；有至少两次完整的管理和执行CSV周期的经验。 Understand GMP, GAMP 5, data integrity principles, and requirements for electronic records and computerized systems, including 21 CFR Part 11 and EU GMP Annex 11. At least 2 full lifecycles on managing and executing project CSV. 具备良好的中文沟通能力；英语能够作为工作语言，能够独立参与或主持英文会议、开展需求讨论、撰写项目文档并汇报项目状态。 Have strong communication skills in Chinese and professional working proficiency in English, including the ability to independently participate in or lead meetings, discuss requirements, write project documentation, and present project status. 能够根据项目需要出差及参与跨时区协作。 Be willing to travel and collaborate across time zones as required by projects. 四、优先条件 / Preferred Qualifications 【加分项】拥有售前支持实战经验：包含客户技术交流、方案编写、POC策划、工作量评估、投标支持者优先 Bonus: Hands-on presales experience including client technical workshop, solution proposal drafting, POC planning, effort estimation and bid support is highly preferred. 【加分项】英语可作为独立对外输出工作语言，可独立完成全英文方案、全英文客户宣讲者优先 Bonus: Advanced English proficiency for independent external communication, capable of delivering full-English proposal and client presentation is a strong plus. 【加分项】具备SCADA/DCS方案设计、对接调试、故障排查实战经验优先 Bonus: Practical experience on SCADA/DCS solution design, integration commissioning and troubleshooting is a strong plus. 具有MES与SAP、LIMS、DCS/SCADA或设备系统的集成经验，熟悉ISA-95和ISA-88。 Experience integrating MES with SAP, LIMS, DCS/SCADA, or equipment systems, and familiarity with ISA-95 and ISA-88. 【加分项】同时掌握两款及以上主流MES产品（PAS-X、西门子Opcenter、Rockwell PharmaSuite等）优先 Bonus: Candidates with hands-on experience of two or more mainstream MES products (PAS-X, Siemens Opcenter, Rockwell PharmaSuite etc.) will be highly preferred. 熟悉至少一种主流生命科学MES平台，例如Körber Werum PAS-X、Rockwell PharmaSuite、Siemens Opcenter Execution Pharma、POMSnet Aquila。 Experience with a major life sciences MES platform, such as Körber Werum PAS-X, Rockwell PharmaSuite, Siemens Opcenter Execution Pharma, POMSnet Aquila. 具有跨国制药企业项目、多工厂模板设计或全球推广经验。 Experience with multinational pharma