锦鲤求职岗位描述
工作地点：上海或苏州
Location: Shanghai or Suzhou
岗位定位
Position Summary
负责基地工程及验证体系质量治理与合规管理，重点支持工程（Facility、Utility、Maintenance、Equipment）及验证活动全生命周期质量管理，推动工程质量体系建设、验证治理、审计检查准备、全球质量标准统一、数字化质量管理及持续改进，确保工程及验证活动符合GMP法规及公司质量体系要求。
Responsible for Engineering & Validation Quality Governance and Compliance Management across manufacturing sites, supporting quality oversight throughout the lifecycle of Facilities, Utilities, Maintenance, Equipment, Qualification and Validation activities. The role drives Engineering Quality Systems, Validation Governance, Inspection Readiness, Global Standard Harmonization, Digital Quality Programs and Continuous Improvement initiatives to ensure compliance with GMP regulations and corporate quality standards.
推动工程及验证团队质量体系能力建设和质量文件卓越化，持续提升偏差、变更、CAPA、风险评估、验证文件及SOP等关键质量文件质量。
Drive quality system capability development and documentation excellence across Engineering & Validation functions, continuously improving the quality of deviations, change controls, CAPAs, risk assessments, validation documentation and SOPs.
岗位职责
Responsibilities
审计检查与法规符合性管理
Audit & Regulatory Compliance Management
负责工程及验证相关客户审计及官方检查的统筹协调，包括审计前准备、现场支持、检查期间问题应答及发现项整改跟踪。
Coordinate client audits and regulatory inspections related to Engineering and Validation, including pre-audit preparation, inspection support, audit response coordination and follow-up of remediation activities.
建立并维护工程及验证审计资源库，包括确认方案、验证报告、法规解读及审计应答资料。
Establish and maintain Engineering & Validation audit resource libraries, including qualification protocols, validation reports, regulatory guidance and inspection support documents.
协调并监督工程及验证相关法规、指南及行业标准的执行，开展法规差距分析，推动整改措施落地。
Coordinate implementation of applicable regulations, guidelines and industry standards, conduct regulatory gap assessments and drive remediation activities.
跟踪国内外法规动态及行业最佳实践，推动工程、维护、设备管理、确认及验证体系持续优化。
Monitor domestic and international regulatory trends and industry best practices to continuously improve engineering, maintenance, equipment management, qualification and validation systems.
工程质量与验证治理
Engineering Quality & Validation Governance
作为工程及验证部门质量合规代表，对设施、公用工程、设备、维护管理及验证活动提供独立的合规监督和专业支持。
Serve as the Quality Compliance representative for Engineering & Validation, providing independent compliance oversight and professional support for facilities, utilities, equipment, maintenance and validation activities.
参与设备确认、公用系统确认、计算机化系统验证（CSV）、工艺验证等活动的合规审核。
Participate in compliance reviews of equipment qualification, utility qualification, computerized system validation (CSV) and process validation activities.
支持验证治理体系建设和持续优化，包括验证总计划（VMP）、验证策略、风险管理及验证生命周期管理。
Support Validation Governance programs, including Validation Master Plans (VMP), qualification strategies, risk management and validation lifecycle management.
参与工程相关变更控制、偏差调查、CAPA及质量风险管理活动。
Participate in change controls, deviation investigations, CAPA management and quality risk management activities.
推动工程与验证相关质量程序、标准及治理机制持续优化。
Drive continuous improvement of Engineering & Validation quality procedures, standards and governance practices.
推动工程及验证相关质量文件质量持续提升，包括但不限于偏差、变更控制、CAPA、风险评估、确认与验证文件、标准操作程序（SOP）、技术报告及审计应答文件等。
Drive continuous improvement of quality documentation across Engineering & Validation functions, including but not limited to deviations, change controls, CAPAs, risk assessments, qualification and validation documents, SOPs, technical reports and audit response documentation.
建立质量文件编写、审核及质量评价标准，推动文件标准化建设，提升文件科学性、合规性、逻辑性、一致性和可追溯性。
Establish documentation authoring, review and quality assessment standards to improve scientific rigor, compliance, logical consistency, standardization and traceability.
跨基地质量治理与持续改进
Cross-Site Quality Governance & Continuous Improvement
推动各基地工程及验证质量标准、管理流程和工作实践的统一与标准化建设。
Drive harmonization and standardization of Engineering & Validation quality standards, management processes and operating practices across sites.
组织跨基地质量协同活动，推动最佳实践共享与推广。
Coordinate cross-site quality collaboration initiatives and promote sharing and deployment of best practices.
建立质量事件、偏差、CAPA、审计发现项及监管发现项经验分享机制。
Establish knowledge-sharing mechanisms for quality events, deviations, CAPAs, audit findings and regulatory observations.
推动同类问题分析、经验教训总结及预防措施实施，降低重复问题发生风险。
Facilitate recurring issue analysis, lessons learned programs and preventive action implementation to reduce repeat occurrences.
协调跨基地工程质量提升项目，跟踪重点质量指标及改进措施执行情况。
Coordinate cross-site quality improvement initiatives and monitor key quality indicators and improvement actions.
数字化质量治理与智能化提升
Digital Quality Governance & Intelligent Quality Improvement
推动工程及验证质量管理数字化建设，建立关键质量指标（KQI）和关键绩效指标（KPI）监控机制。
Drive digital quality initiatives by establishing Key Quality Indicators (KQIs) and Key Performance Indicators (KPIs).
建立工程及验证质量趋势分析机制，定期开展偏差、CAPA、变更、风险评估、审计发现项、监管发现项、验证活动及关键质量指标分析。
Establish Engineering & Validation quality trending programs covering deviations, CAPAs, change controls, risk assessments, audit findings, regulatory observations, validation activities and key quality metrics.
识别重复发生问题、系统性风险及质量薄弱环节，推动预防措施及持续改进项目实施。
Identify recurring issues, systemic risks and quality vulnerabilities, and drive preventive actions and continuous improvement initiatives.
组织质量管理回顾，定期向管理层汇报质量趋势、合规风险、改进计划及执行效果。
Lead quality management reviews and provide periodic reporting to management on quality trends, compliance risks, improvement plans and effectiveness results.
利用统计分析、Power BI及数字化工具开展质量数据挖掘，预测潜在风险并支持主动质量管理。
Leverage statistical analysis, Power BI and digital tools to identify trends, predict potential risks and support proactive quality management.
推动工程及验证质量数据治理体系建设，提升数据质量、数据完整性及质量分析能力。
Drive Engineering & Validation quality data governance standards to improve data quality, data integrity and analytical capability.
推动Power BI、数字化仪表盘、自动化报告及质量管理平台在工程与验证管理中的应用。
Promote the application of Power BI, digital dashboards, automated reporting and quality management platforms.
探索人工智能（AI）在偏差分析、趋势识别、风险预测、知识管理、同类问题分析及经验库建设中的应用。
Explore the application of Artificial Intelligence (AI) in deviation analysis, trend identification, risk prediction, knowledge management, recurring issue analysis and lessons-learned programs.
支持工程及验证数字化转型项目建设，推动数据治理和数字化运营能力提升。
Support Engineering & Validation digital transformation initiatives through data governance and digital operations excellence.
精益管理与卓越运营提升
Lean Management & Operational Excellence
推动精益管理理念在工程及验证体系中的应用。
Drive the application of Lean Management principles within Engineering & Validation processes.
结合偏差、CAPA、审计发现项、质量趋势及风险评估数据推动根本原因分析（RCA）及持续改进项目实施。
Leverage deviations, CAPAs, audit findings, quality trending and risk assessment data to drive root cause analysis (RCA) and continuous improvement initiatives.
推动标准化、可视化管理及流程优化。
Promote standardization, visual management and process optimization.
应用Lean、Six Sigma、Kaizen、A3 Problem Solving及Value Stream Mapping等工具解决系统性问题。
Apply Lean, Six Sigma, Kaizen, A3 Problem Solving and Value Stream Mapping methodologies to address systemic issues.
持续提升工程及验证体系运营效率和管理成熟度。
Continuously improve operational efficiency and organizational maturity within Engineering & Validation.
培训与质量文化建设
Training & Quality Culture Development
组织开展工程及验证法规、质量及合规培训。
Organize regulatory, quality and compliance training programs related to Engineering & Validation.
建立质量体系能力提升机制，持续提升团队质量体系理解、法规应用能力及质量风险管理能力。
Establish quality system capability development programs to strengthen organizational quality system knowledge, regulatory application capability and quality risk management competency.
推动法规、质量体系、偏差调查、风险评估、CAPA、技术写作及审计检查准备等关键能力建设。
Drive capability development in regulatory compliance, quality systems, deviation investigations, risk assessments, CAPA management, technical writing and inspection readiness.
传播最新法规要求、行业标准及最佳实践。
Promote awareness of the latest regulatory requirements, industry standards and best practices.
配合质量保证部门，确保工程及验证管理要求与公司整体GMP质量体系保持一致。
Collaborate with the Quality Assurance organization to ensure Engineering & Validation practices remain aligned with the overall GMP Quality Management System.
推动质量文化建设和持续改进活动开展。
Support quality culture development and continuous improvement initiatives.
海外基地工程及验证合规支持
Global Engineering & Validation Compliance Support
支持海外基地工程及验证体系建设与持续优化，确保工程、设施、公用工程、设备、维护及验证活动符合公司全球质量标准及当地法规要求。
Support the development and continuous improvement of Engineering & Validation systems at global manufacturing sites, ensuring engineering, facilities, utilities, equipment, maintenance and validation activities comply with corporate quality standards and local regulatory requirements.
支持海外基地工程及验证相关质量体系评估、差距分析及整改提升活动。
Support quality system assessments, gap analyses and continuous improvement initiatives for overseas Engineering & Validation organizations.
参与海外基地工程、确认及验证活动的质量审核与合规管理，推动工程质量标准全球统一。
Participate in quality reviews and compliance management for engineering, qualification and validation activities at overseas sites, promoting global quality standard harmonization.
支持海外基地客户审计、官方检查及检查准备工作，提高全球工程与验证体系检查准备水平。
Support client audits, regulatory inspections and inspection readiness activities at overseas sites.
跟踪国际法规、行业标准及全球质量管理趋势，推动工程与验证管理体系持续优化。
Monitor international regulations, industry standards and global quality trends to drive continuous enhancement of Engineering & Validation management systems.
支持全球工程与验证数字化转型项目，推动质量数据治理、可视化管理及智能化质量管理模式建设。
Support global digital transformation initiatives for Engineering & Validation through data governance, visual management and intelligent quality management solutions.
任职要求
Qualifications
教育背景
Education
硕士学历优先，优秀本科毕业生亦可考虑。
Master’s degree is preferred. Outstanding candidates with a Bachelor's degree will also be considered.
制药工程、生物工程、生物制药、化学工程、机械工程、自动化、质量管理或相关专业。
Major in Pharmaceutical Engineering, Biotechnology, Biopharmaceutical Engineering, Chemical Engineering, Mechanical Engineering, Automation, Quality Management or related disciplines.
工作经验
Experience
5年以上GMP制药行业质量、验证、工程合规或审计相关工作经验。
Minimum 5 years of experience in Quality, Validation, Engineering Compliance or Audit-related functions within the GMP pharmaceutical industry.
具有工程QA或验证QA背景者优先。
Candidates with Engineering QA or Validation QA backgrounds are strongly preferred.
具备以下任一领域相关经验：
Candidates should have experience in one or more of the following areas:
验证QA背景（Validation QA Background）
Validation QA
Qualification QA
CSV QA
Validation Compliance
Validation Governance
工程QA背景（Engineering QA Background）
Facility QA
Utility QA
Maintenance QA
Equipment QA
Engineering Compliance
Engineering Quality Assurance
具有工程质量管理、验证治理、审计检查准备、质量趋势分析、质量体系建设或质量治理经验者优先。
Experience in Engineering Quality Management, Validation Governance, Inspection Readiness, Quality Trending, Quality Systems Development or Quality Governance is preferred.
具有跨基地项目支持、海外基地支持、国际审计或全球质量体系建设经验者优先。
Experience supporting cross-site projects, overseas manufacturing sites, international audits or global quality system initiatives is preferred.
专业能力
Technical Competencies
熟悉FDA、EMA、NMPA GMP法规以及ICH相关指南要求。
Strong knowledge of FDA, EMA and NMPA GMP regulations, as well as applicable ICH guidelines.
熟悉EU GMP Annex 1、Annex 11等法规要求。
Good understanding of EU GMP Annex 1, Annex 11 and related regulatory requirements.
熟悉设施、公用工程、设备及维护管理全生命周期管理要求。
Strong understanding of facilities, utilities, equipment and maintenance lifecycle management.
熟悉设备确认、公用系统确认、CSV、工艺验证及持续工艺验证要求。
Strong understanding of equipment qualification, utility qualification, CSV, process validation and continued process verification.
熟悉偏差管理、变更控制、CAPA及质量风险管理（QRM）。
Familiar with deviation management, change control, CAPA and Quality Risk Management (QRM).
熟悉ISPE、GAMP5、PDA及ASTM相关指南者优先。
Knowledge of ISPE, GAMP5, PDA and ASTM guidance is preferred.
具备数字化质量管理、Power BI、数据分析或数字化仪表盘经验者优先。
Experience in digital quality management, Power BI, data analytics or dashboard development is preferred.
具备AI辅助质量管理实践经验者优先。
Experience applying AI-enabled quality management solutions is preferred.
具备Lean、Six Sigma、Operational Excellence、A3 Problem Solving或Value Stream Mapping经验者优先。
Experience in Lean, Six Sigma, Operational Excellence, A3 Problem Solving or Value Stream Mapping is preferred.
综合能力
Competencies
具备工程与验证质量治理及合规管理思维。
Demonstrated mindset in Engineering & Validation Quality Governance and Compliance Management.
具备优秀的数据分析能力、风险识别能力及系统性问题解决能力。
Strong analytical, risk assessment and systematic problem-solving skills.
具备推动跨部门、跨基地质量标准统一及持续改进项目落地能力。
Demonstrated capability to drive cross-functional and cross-site quality harmonization and continuous improvement initiatives.
具备推动全球协同、海外基地支持及国际项目管理能力。
Demonstrated capability in global collaboration, overseas site support and international project coordination.
具备推动数字化转型、质量体系优化及组织能力提升能力。
Demonstrated capability in digital transformation, quality system optimization and organizational capability development.
具备优秀的沟通协调能力及良好的英语听说读写能力，能够熟练阅读和理解英文法规、技术文件及审计资料。
Strong communication and English language skills with the ability to interpret regulatory, technical and audit documentation.