（高级）验证工程师 (Senior) Validation Engineer

岗位概述

Position Summary

负责厂房、设施、公用系统、生产设备、灭菌系统、清洁工艺、运输系统及计算机化系统等全生命周期验证与确认工作，确保相关系统持续符合法规要求、公司质量体系及全球客户标准。

Responsible for lifecycle qualification and validation activities covering facilities, utilities, manufacturing equipment, sterilization systems, cleaning processes, transportation systems, and computerized systems, ensuring continuous compliance with regulatory requirements, company quality systems, and global customer expectations.

参与验证体系建设与持续优化，支持项目建设、技术转移、商业化生产及工厂持续运营。

Participate in validation system establishment and continuous improvement to support capital projects, technology transfer, commercial manufacturing, and routine site operations.

岗位职责

Key Responsibilities

1. 验证体系建设与生命周期管理

Validation System & Lifecycle Management

负责验证主计划（VMP）的制定、执行、维护及年度回顾。

Develop, execute, maintain, and periodically review the Validation Master Plan (VMP).

根据法规要求及业务需求起草、修订验证相关SOP、风险评估及技术标准。

Draft, revise, and continuously improve validation SOPs, risk assessments, and technical standards in accordance with regulatory requirements and business needs.

建立并维护验证生命周期管理体系，确保系统持续保持验证状态。

Establish and maintain a validation lifecycle management system to ensure systems remain in a validated state.

组织并执行周期性再确认、再验证及持续验证活动。

Organize and execute periodic requalification, revalidation, and continued verification activities.

2. 厂房、设施及公用系统验证

Facility, Utility and Infrastructure Qualification

负责厂房、洁净区及关键设施的确认与验证工作。

Perform qualification and validation activities for facilities, cleanrooms, and critical infrastructure systems.

负责HVAC系统的DQ、IQ、OQ、PQ及再确认活动。

Lead DQ, IQ, OQ, PQ, and requalification activities for HVAC systems.

负责PW、WFI、纯蒸汽（PS）、压缩空气及工艺气体系统验证。

Support qualification and validation of PW, WFI, Pure Steam, compressed air, and process gas systems.

负责EMS、BMS、CTU、冷库及温控系统确认与再确认。

Perform qualification and requalification activities for EMS, BMS, CTU, cold rooms, and temperature-controlled systems.

确保所有设施及公用系统符合GMP及法规要求。

Ensure all facilities and utility systems comply with GMP and regulatory requirements.

3. 设备确认与验证

Equipment Qualification & Validation

负责生产设备、实验室设备及辅助系统全生命周期确认管理。

Manage lifecycle qualification activities for manufacturing equipment, laboratory instruments, and supporting systems.

参与用户需求说明（URS）、风险评估、设计确认（DQ）及供应商管理活动。

Participate in User Requirement Specifications (URS), risk assessments, Design Qualification (DQ), and supplier management activities.

组织并执行FAT、SAT、IQ、OQ及PQ活动。

Organize and execute FAT, SAT, IQ, OQ, and PQ activities.

编写、审核和维护验证方案、报告及相关文件。

Prepare, review, and maintain validation protocols, reports, and supporting documentation.

4. 灭菌验证

Sterilization Validation

负责湿热灭菌工艺验证及再验证活动。

Execute moist heat sterilization validation and requalification activities.

参与灭菌柜、去热原隧道、冻干机及相关系统确认活动。

Participate in qualification activities for autoclaves, depyrogenation tunnels, lyophilizers, and associated systems.

参与灭菌工艺开发、性能确认及持续监控工作。

Support sterilization process development, performance qualification, and ongoing monitoring activities.

确保灭菌工艺符合FDA、EMA、NMPA及PIC/S法规要求。

Ensure sterilization processes comply with FDA, EMA, NMPA, and PIC/S regulatory expectations.

5. 清洁验证与持续清洁确认

Cleaning Validation & Continued Cleaning Verification

负责清洁验证策略制定与执行。

Develop and execute cleaning validation strategies.

参与Worst Case选择、MACO计算及风险评估。

Participate in worst-case selection, MACO calculations, and risk assessments.

负责清洁开发研究、回收率研究及验证取样活动。

Support cleaning development studies, recovery studies, and validation sampling activities.

负责清洁验证、加强型清洁确认及持续清洁确认活动。

Execute cleaning validation, enhanced cleaning verification, and continued cleaning verification activities.

确保清洁工艺持续符合GMP及法规要求。

Ensure cleaning processes remain compliant with GMP and regulatory requirements.

6. 运输验证与冷链验证

Shipping Qualification & Cold Chain Validation

参与常温及冷链运输验证工作。

Participate in ambient and cold-chain shipping qualification activities.

负责运输风险评估、温度分布研究及验证报告编写。

Conduct transportation risk assessments, temperature mapping studies, and validation report preparation.

支持商业化产品运输验证状态维护。

Support maintenance of validated status for commercial shipping systems.

7. 计算机化系统验证（CSV）

Computerized System Validation (CSV)

参与MES、LIMS、EMS、BMS、SCADA及其他GxP计算机化系统验证活动。

Participate in validation activities for MES, LIMS, EMS, BMS, SCADA, and other GxP computerized systems.

支持计算机化系统生命周期管理、数据完整性评估及风险管理。

Support computerized system lifecycle management, data integrity assessments, and risk management activities.

8. 质量体系支持

Quality System Support

参与验证相关偏差调查及根本原因分析。

Participate in validation-related deviation investigations and root cause analysis.

参与验证影响评估及风险管理活动。

Provide validation impact assessments and support risk management activities.

负责验证相关CAPA的制定、执行及效果确认。

Develop, implement, and verify the effectiveness of validation-related CAPAs.

支持变更控制、年度回顾及持续改进工作。

Support change control, annual reviews, and continuous improvement initiatives.

9. 审计支持

Audit Support

支持FDA、EMA、NMPA及客户审计。

Support FDA, EMA, NMPA, and customer audits.

参与审计发现项回复及整改措施制定。

Participate in audit response activities and development of corrective actions.

参与验证体系持续优化及数字化提升项目。

Support continuous improvement and digital transformation initiatives within the validation program.

推动验证流程标准化、风险导向及生命周期管理理念落地。

Drive standardization, risk-based approaches, and lifecycle validation principles across the organization.

任职要求

Qualifications

本科及以上学历，制药工程、生物工程、化学工程、机械工程、自动化或相关专业。

Bachelor’s degree or above in Pharmaceutical Engineering, Bioengineering, Chemical Engineering, Mechanical Engineering, Automation, or a related discipline.

验证工程师需具备3年以上制药行业验证、质量或工程相关经验。

Validation Engineer candidates should possess at least 3 years of experience in pharmaceutical validation, quality, or engineering functions.

高级验证工程师需具备5年以上大型制药企业验证管理经验。

Senior Validation Engineer candidates should possess at least 5 years of validation experience within large pharmaceutical organizations.

熟悉FDA、EMA、NMPA GMP法规及ICH相关指南。

Strong knowledge of FDA, EMA, NMPA GMP regulations and applicable ICH guidelines.

熟悉厂房、设施、公用系统、设备、灭菌、清洁及运输验证。

Hands-on experience in facility, utility, equipment, sterilization, cleaning, and shipping validation.

具备良好的风险评估、偏差调查及CAPA管理能力。

Strong capabilities in risk assessment, deviation investigation, and CAPA management.

具备良好的中英文技术文件编写能力。

Strong technical writing skills in both Chinese and English.

具备良好的沟通协调能力及跨部门合作能力。

Excellent communication, coordination, and cross-functional collaboration skills.

优先考虑条件

Preferred Qualifications

具有生物制药行业厂房及公用系统验证经验。

Experience in facility and utility qualification within the biopharmaceutical industry.

具有大型生产设备及实验室设备确认经验。

Experience in qualification of manufacturing equipment and laboratory instruments.

具有湿热灭菌、灭菌柜、去热原隧道或冻干机验证经验。

Experience in moist heat sterilization, autoclave, depyrogenation tunnel, or lyophilizer qualification.

具有清洁验证及持续工艺确认经验。

Experience in cleaning validation and continued process verification.

具有MES、LIMS、SCADA、EMS或BMS等CSV经验。

Experience in computerized system validation for MES, LIMS, SCADA, EMS, or BMS platforms.

具有FDA、EMA、MHRA、PMDA或国际客户审计支持经验。

Experience supporting FDA, EMA, MHRA, PMDA, or international customer inspections.

具有大型生物制药项目建设、技术转移或商业化验证经验。

Experience supporting large-scale biopharmaceutical projects, technology transfer, or commercial manufacturing validation.