(Sr.)验证工程师-设备设施/清洁验证hz

/ Job Description 负责验证相关工作的实施与技术支持，涵盖设备设施验证、制剂工艺验证及清洁验证，确保系统持续符合GMP及法规要求，支撑生产稳定运行和产品质量合规。 Responsible for execution and technical support of validation activities, including equipment and facility validation, drug product process validation, and cleaning validation, ensuring systems remain compliant with GMP and regulatory

to support stable production and product quality. ________________________________________ 岗位职责 / Job Responsibilities

1. 01

   验证执行与管理 负责验证活动的执行，包括方案编写、现场执行及报告总结。 Execute validation activities, including protocol development, on-site execution, and report preparation. 确保验证活动按计划完成并符合质量和合规要求。 Ensure validation activities are completed on schedule and in compliance with quality and regulatory requirements. ________________________________________

2. 02

   设备及设施验证 参与设备及公用设施验证，包括安装确认、运行确认及性能确认。 Participate in equipment and utility validation, including IQ, OQ, and PQ activities. 支持厂房及系统验证，确保设施满足GMP要求。 Support facility qualification to ensure compliance with GMP standards. ________________________________________

3. 03

   制剂工艺验证支持 参与制剂生产相关工艺验证及技术转移。 Support drug product process validation and technology transfer activities. 协助工艺参数确认及验证数据分析。 Assist in process parameter confirmation and validation data analysis. 确保工艺稳定性及产品一致性。 Ensure process stability and product consistency. ________________________________________

4. 04

   清洁验证管理 参与清洁验证活动，包括方案制定、执行及结果分析。 Participate in cleaning validation activities, including protocol development, execution, and result evaluation. 确保清洁效果满足法规及质量要求。 Ensure cleaning effectiveness meets regulatory and quality requirements. 支持再验证及持续验证工作。 Support revalidation and continued verification activities. ________________________________________

5. 05

   工程项目验证支持 参与新建项目及设备改造项目中的验证工作。 Support validation activities in new construction and retrofit projects. 包括FAT、SAT及C&Q活动支持。 Support FAT, SAT, and commissioning & qualification activities. 确保项目从工程向生产顺利交接。 Ensure smooth transition from project phase to operation. ________________________________________

6. 06

   偏差与CAPA管理 参与验证相关偏差调查及问题分析。 Support deviation investigations related to validation. 推动CAPA实施并跟踪整改效果。 Drive CAPA implementation and follow-up on effectiveness. 支持变更及风险评估管理。 Support change control and risk assessment processes. ________________________________________

7. 07

   验证文件与体系维护 起草及维护验证相关文件，包括验证方案及报告。 Prepare and maintain validation documentation, including protocols and reports. 确保文件符合规范并具备可追溯性。 Ensure documentation is compliant and traceable. ________________________________________

8. 08

   数据分析与持续改进 参与验证数据收集与分析。 Collect and analyze validation data. 持续优化验证策略及执行方式。 Continuously improve validation approaches and execution efficiency. ________________________________________ 任职要求 / Job Requirements 教育背景 / Education 本科及以上学历，制药工程、生物工程、化学工程或相关专业。 Bachelor’s degree or above in Pharmaceutical Engineering, Bioengineering, Chemical Engineering, or related fields. ________________________________________ 工作经验 / Experience 3–5年以上验证相关工作经验。 Minimum 3–5 years of experience in validation-related roles. 具备设备设施、制剂或清洁验证经验优先。 Experience in equipment/facility, drug product, or cleaning validation is preferred. ________________________________________ 专业能力 / Technical Competence 熟悉验证流程及方法，包括IQ/OQ/PQ。 Familiar with validation processes and methodologies, including IQ/OQ/PQ. 了解工艺验证及清洁验证相关要求。 Basic understanding of process validation and cleaning validation. 熟悉GMP法规及质量体系要求。 Familiar with GMP regulations and quality systems. 具备数据分析及问题解决能力。 Strong data analysis and problem-solving capability. ________________________________________ 综合能力 / Soft Skills 具备良好的沟通能力及团队协作能力。 Strong communication and teamwork skills. 具备较强执行力及责任心。 Strong execution and accountability. 具备持续改进意识。 Continuous improvement mindset.