XDS_MSAT 工艺技术工程师（工艺验证方向）*4

applies risk- and data-based validation strategies, cross-functional collaboration, and shop-floor technical support to ensure robust, reproducible, and controlled manufacturing at commercial scale.

工作职责 / Key Responsibilities

1. 工艺验证策略与项目规划：根据产品生命周期阶段、工艺控制策略及法规要求，参与或主导抗体和偶联项目的工艺验证总体策略、主计划、PPQ方案及取样策略设计，明确验证范围、接受标准、批次策略、前置条件和风险控制措施。

Process validation strategy and planning: Participate in or lead the overall validation strategy, validation master plan, PPQ protocols, and sampling strategy for antibody and bioconjugation projects based on lifecycle stage, process control strategy, and regulatory requirements. Define scope, acceptance criteria, batch strategy, prerequisites, and risk controls.

2. PPQ准备与执行：统筹并跟踪PPQ readiness，包括厂房、设备、物料、工艺文件、分析方法、人员培训及支持性研究等；组织跨部门准备评审，推动差距关闭，并在生产现场提供技术支持，确保方案合规执行和数据完整。

PPQ readiness and execution: Coordinate and track PPQ readiness covering facilities, equipment, materials, process documents, analytical methods, personnel training, and supporting studies. Facilitate cross-functional readiness reviews, drive gap closure, and provide on-site technical support to ensure compliant execution and data integrity.

3. 验证文件与技术结论：起草、审核并推动工艺验证相关文件的签批，包括验证主计划、方案、风险评估、偏差影响评估、验证报告及生产总结报告；对关键工艺参数、工艺性能属性和关键质量属性数据进行汇总、统计分析和科学解释，形成清晰、可追溯的验证结论。

Validation documentation and technical conclusions: Author, review, and drive approval of validation master plans, protocols, risk assessments, deviation impact assessments, validation reports, and campaign summary reports. Compile, statistically evaluate, and scientifically interpret CPP, process performance attribute, and CQA data to establish clear and traceable validation conclusions.

4. 后期技术转移衔接：在项目进入后期及PPQ阶段时前置介入，评估Facility/Process Fit、工艺放大风险、设备能力及控制策略差距；与原技术转移负责人协同，确保工艺文件、验证文件和生产执行要求一致并顺利交接。

Late-stage technology transfer interface: Engage early as projects enter late-stage and PPQ phases to assess facility/process fit, scale-up risks, equipment capability, and control strategy gaps. Partner with the technology transfer lead to align process documents, validation deliverables, and manufacturing requirements for an effective handover.

5. 质量事件与问题解决：针对PPQ及相关生产活动中的偏差、变更和风险事项提供技术评估；组织或参与根因分析、影响评估、CAPA制定和有效性跟踪，判断事件对验证状态及申报结论的影响，并推动问题闭环。

Quality events and troubleshooting: Provide technical assessment for deviations, changes, and risks arising from PPQ and related manufacturing activities. Lead or support root cause analysis, impact assessment, CAPA definition, and effectiveness follow-up; determine impact on validation status and regulatory conclusions and drive closure.

6. 申报与审计支持：撰写或审核IND/BLA等申报资料中的工艺验证相关内容，准备验证策略、关键数据和科学论证；作为工艺验证SME支持或领导客户审计、NMPA/FDA/EMA等官方检查、Mock audit及审计问答和整改。

Regulatory filing and inspection support: Author or review process-validation content for IND/BLA dossiers and prepare validation strategies, key data, and scientific rationale. Serve as a process validation SME to support or lead client audits, NMPA/FDA/EMA inspections, mock audits, audit responses, and remediation activities.

7. 客户与跨职能协同：与客户、CMC、生产、QA、QC、工程、供应链和工艺开发等团队保持高效沟通，更新验证进展、关键风险、决策事项和交付状态；明确职责边界、升级重大风险并推动项目按计划交付。

Client and cross-functional collaboration: Communicate effectively with clients and CMC, Manufacturing, QA, QC, Engineering, Supply Chain, and Process Development teams. Provide updates on validation progress, key risks, decisions, and deliverables; clarify ownership, escalate critical risks, and drive on-time delivery.

8. 持续工艺确认（CPV）支持：协助制定和维护CPV计划、监测指标及统计方法；按计划协助收集、核对和趋势分析商业化生产过程及质量数据，识别异常趋势和潜在工艺漂移，支持周期性回顾、调查、风险评估及改进措施跟踪，为持续验证状态评估提供技术输入。

Continued Process Verification (CPV) support: Assist in developing and maintaining CPV plans, monitoring metrics, and statistical methods. Assist in Collect, verify, and trend commercial manufacturing process and quality data as planned; identify adverse trends and potential process drift; support periodic reviews, investigations, risk assessments, and follow-up of improvement actions; and provide technical input to the assessment of the continued validated state.

9. 体系建设与持续改进：参与工艺验证平台、SOP、模板、检查清单、知识库和培训体系的建立与持续优化；沉淀项目经验，推动验证流程标准化、数字化、数据分析能力提升及最佳实践复用。

Capability building and continuous improvement: Contribute to the development and continuous improvement of the process validation platform, SOPs, templates, checklists, knowledge base, and training system. Capture project learning and advance standardization, digitalization, data analytics, and reuse of best practices.

任职要求 / Qualifications

1. 教育背景 / Education

全日制硕士及以上学历，化学工程、生物工程、生物学、药学、生物化学或其他生命科学相关专业。

Master’s degree or above in chemical engineering, bioengineering, biology, pharmacy, biochemistry, or another life-science-related discipline.

2. 相关经验 / Experience

优先考虑具备3年以上大分子药物、抗体或偶联药物工艺技术、技术转移、工艺验证或GMP生产支持经验的候选人；具有完整PPQ项目经验者优先。

3+ years of experience in process technology, technology transfer, process validation, or GMP manufacturing support for biologics, antibodies, or bioconjugates is preferred. End-to-end PPQ experience is a strong advantage.

3. 专业能力 / Technical Expertise

理解生物药或偶联药物生产工艺、工艺放大、控制策略和验证生命周期；熟悉PPQ方案/报告、风险评估、偏差与变更管理。具备统计分析、数据趋势分析或Minitab等工具应用经验者优先。

Understanding of biologics or bioconjugation manufacturing, scale-up, control strategy, and the validation lifecycle. Familiarity with PPQ protocols/reports, risk assessment, deviation, and change management. Experience with statistical analysis, data trending, or tools such as Minitab is preferred.

4. 法规与GMP / GMP and Regulatory

熟悉中国GMP及主要国际工艺验证法规和指南要求；具备客户审计、官方检查或申报支持经验者优先。

Knowledge of China GMP and major international expectations for process validation. Experience supporting client audits, regulatory inspections, or filings is preferred.

5. 沟通与项目管理 / Communication and Project Management

具备良好的跨部门协同、项目推进、会议组织、书面表达及技术汇报能力，能够在多项目并行和紧迫时间线下识别优先级并推动问题闭环。

Strong cross-functional collaboration, project execution, meeting facilitation, technical writing, and presentation skills. Able to prioritize and drive issue closure across multiple projects and demanding timelines.

6. 语言能力 / Language

具备良好的中英文读写及口语沟通能力，能够独立撰写双语技术文件，并与国内外客户进行技术沟通。

Strong written and spoken Chinese and English, with the ability to independently prepare bilingual technical documents and communicate technical topics with global clients.

7. 个人素质 / Personal Attributes

责任心强，逻辑清晰，具备主动学习、科学判断、风险意识和问题解决能力；坚持数据完整性和GMP合规，具有团队合作精神和适应现场支持安排的灵活性。

Strong ownership, logical thinking, learning agility, scientific judgment, risk awareness, and problem-solving ability. Demonstrates commitment to data integrity and GMP compliance, teamwork, and flexibility for shop-floor support.

(PPQ) through regulatory filing and inspection readiness.