Job Description

岗位概述 – 基本职能和职责 Job overview - basic functions and responsibilities

负责工厂BAS楼宇自控系统、EMS环境监控系统、TSI环境监控系统、TTS赋码系统、短信报警系统、2车间及动物房工艺用CCTV等自动化系统包括软硬件整体的技术支持、日常维护和项目实施；

Responsible for the factory BAS building automation system, EMS environmental monitoring system, TSI environmental monitoring system, TTS coding system, SMS alarm system, automation systems such as CCTV for workshop 2 and animal room, including overall technical support for software and hardware, daily maintenance, and project implementation;

负责工厂GMP设备自动化控制系统的技术支持和配合设备维护保养工作；

Responsible for technical support of the factory GMP equipment automation control system and cooperation in equipment maintenance work;

提供工厂其他设备自动化控制系统的技术支持和配合设备维护保养工作；

Provide technical support for other equipment automation control systems in the factory and cooperate in equipment maintenance work;

提供自动化系统项目管理和实施过程中的技术及计算机系统验证支持。

Provide technical and computer system validation support during the management and implementation of automation system projects.

主要职责 Key responsibilities

-战略Strategy：

1. 倡导并运用MPS和持续改进的理念和工作方式，通过积极寻求改进机会，提出提高工厂自动化系统运作效率和服务质量的努力方向；

Advocate and apply MPS and continuous improvement concepts and work methods, actively seeking improvement opportunities, and propose directions for efforts to enhance the operational efficiency and service quality of factory automation systems;

1. 不断提高自动化系统运行的服务意识和安全质量环保意识，持续提高系统管理绩效；

Continuously improve the service awareness and safety quality environmental awareness of automation system operations, and continuously enhance system management performance;

1. 配合设备维护工程师和信息化工程师解决自动化及集成系统的问题和改进项目。

Collaborate with equipment maintenance engineers and information engineers to solve issues and improvement projects related to automation and integration systems.

-合规Compliance：

1. 学习和遵守工厂EHS和GMP合规性要求，在日常工作中，符合EHS和GMP合规性；

Learn and comply with factory EHS and GMP compliance requirements, ensuring EHS and GMP compliance in daily work;

1. 负责符合质量和安全标准、公司政策和程序的IT和OT运维模式的活动、结果和文件管理；

Responsible for the activities, results, and document management of IT and OT operation and maintenance models that meet quality and safety standards, company policies, and procedures;

1. 对工作中发现的合规问题，积极反馈和纠正。

Actively feedback and correct compliance issues discovered in work.

-运作Operations：

1. 制定、定期更新和实施管辖系统和设备设施包括在SDLC系统生命周期中定义的SOP，确保运行稳定可靠、降低运作成本。

Develop, regularly update, and implement SOPs defined in the SDLC system lifecycle for systems and equipment facilities under jurisdiction, ensuring stable and reliable operation and reducing operational costs.

1. 制定和维护备品备件管理和采购计划，完成系统周期性回顾，并根据周期性回顾结果调整备件库存；

Develop and maintain spare parts management and procurement plans, complete periodic system reviews, and adjust spare parts inventory based on review results;

1. 独立或者配合工程设备维护工程师做好各系统的自动化控制系统维护保养工作，包括自动化控制系统的变更，解决系统自动化控制出现的问题；

Independently or in collaboration with engineering equipment maintenance engineers, perform maintenance and upkeep of automation control systems for various systems, including changes to automation control systems and resolving issues in the automation system;

1. 其他工作： 配合组织内IT和OT的同事完成按需分配的任务。

Other tasks: Collaborate with IT and OT colleagues within the organization to complete tasks assigned as needed.

-财务Finance:

1. 负责BAS/EMS/TSI/工艺CCTV/工艺自动系统等职责内的系统外部服务从计划到采购和验收的费用，确保费用控制在预算范围内；

Responsible for the costs of external services for systems under responsibility such as BAS/EMS/TSI/process CCTV/process automation systems, from planning to procurement and acceptance, ensuring cost control within budget;

1. 根据工厂成本控制计划，寻求节能减排和降本增效的机会；

Seek opportunities for energy saving, emission reduction, and cost reduction and efficiency improvement according to the factory cost control plan;

1. 有效降低自动化系统备品库存，定期完成盘点；有效进行固定资产管理。

Effectively reduce the inventory of automation system spare parts, complete regular inventory checks; effectively manage fixed assets.

质量职责Quality Responsibilities

1. 在工作中理解并严格遵守GMP要求，并监督本区域所有GMP活动实施的合规性，确保生产出符合客户要求和法规要求的产品；

Understand and strictly comply with the requirements of GMP in the work, and supervise the compliance of all GMP activities in the region to ensure the production of products that meet the requirements of customers and regulations;

1. 确保每一个本部门的偏差事件得到有效和彻底的调查，找到根本原因，并制定有效的CAPA；

Ensure that each deviation incident of the department is effectively and thoroughly investigated, find the root cause, and develop effective CAPA;

1. 支持质量部门的职责和工作，与质量部保持良好的沟通。

Support the responsibilities and work of the quality department, and keep good communication with the quality department

1. 在工作中具有良好的质量意识，理解GMP要求，并严格按照程序执行GMP操作；

Have good quality awareness in work, understand the requirements of GMP, and strictly follow the procedures to implement GMP operations;

1. 严格按照GMP文件记录的要求，对各项GMP操作进行真实、准确、完整、及时地记录；

Record all GMP operations in a true, accurate, complete and timely manner in strict accordance with the requirements of GMP documents;

1. 真实，准确和及时的报告各种异常情况；

Truthful, accurate and timely reporting of various abnormal situations;

1. 积极参加工厂各种GMP培训。

Actively participated in various GMP trainings in the factory.

最低任职要求 Minimum requirements

在招聘本岗位任职者时的最低要求，如果公司提供相应的培训与指导，也可根据招聘政策相应降低。包括：

The minimum requirements for hiring candidates for this position can be appropriately reduced according to recruitment policies if the company provides relevant training and guidance. Including:

教育程度：工程及机电相关专业大学本科及以上学历；

Education level: Bachelor's degree or above in engineering and electromechanical-related fields;

工作经验：8年以上制药行业自动化相关的工作经验；

Work experience: Over 8 years of work experience in automation related to the pharmaceutical industry;

特殊技能：良好的英语沟通和书写能力，熟悉通用自动化控制系统软硬件的选型、配置、编程和故障排查及修复。

Special skills: Good English communication and writing skills, familiar with the selection, configuration, programming, and troubleshooting and repair of general automation control system from software and hardware failures.

Required Skills:

Automation Systems, English Language, Equipment Automation, Laboratory Equipment Calibration, Lean Manufacturing, Manufacturing Production, Safety Quality, Standard Operating Procedure (SOP)

Preferred Skills:

Vaccine Manufacturing

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Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2026

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