{"id":961126,"url":"https://alion.io/job/astrazeneca-lead-principal-engineer-packaging-process","title":"Lead /Principal Engineer, Packaging Process","company":{"id":13195,"name":"AstraZeneca","domain":"astrazeneca.com","url":"https://alion.io/company/astra-zeneca","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":93,"open_postings":167,"ghost_share":0.012,"stale_share":0.383,"repost_share":0.108,"time_to_fill_p50_days":19,"computed_at":"2026-11-07T05:47:08Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Wuxi, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":32000,"max_usd":83000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":2629},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-09-16T10:10:51Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-11-08T03:13:46Z","board_verified":true,"closed_at":null,"days_open":52,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":52},"description":"Typical Accountabilities\n主要职责\nQualification and Validation\n确认和验证\nTo update SVMP and ensure the visibility of validation plan execution status across the site;\n更新工厂验证主计划，确保其执行状态的可见性; \nTo coordinate with the site QSR implementation;\n协调工厂QSR的实施\nTo give the training on the validation concept and local validation document requirement as requested;\n根据要求，对工厂验证概念和验证文件进行培训; \nTo draft VMP/VP as appropriate;\n起草验证主计划/计划（如适用）; \nTo review and approve the validation doc as appropriate;\n审核和批准验证文件（如适用）; \nBe as the validation representative to facilitate the validation work across the project;\n作为验证代表，推进整个项目的验证工作; \nBe as the validation representative to do the validation assessment for each change control via risk-based approach;\n作为验证代表，对每个变更控制在考虑风险的基础上进行验证评估; \nTo generate/maintain the validation Doc template for each type of validation;\n制定/维护验证模板; \nTo generate/maintain the validation training package.\n制定/维护验证培训材料。\nManage qualification and validation related change activities, e.g., supply switch over management, validation batches release management, etc.,\n管理验证相关的其他活动，比如供应切换，验证批的放行管理等等。\nProcess Development and Improvement\n工艺开发和优化\nInvestigate issues encountered during routine production; provide the technical evaluations and studies (e.g. DOE) to drive process robustness. \n调查日常生产过程中遇到的问题, 进行技术评估和研究(比如实验设计)，改进工艺稳健性。\nTake product and process ownership to conduct CPV, identify improvement opportunities, address the risks, and take proactive actions.\n持续工艺确认， 识别风险和机会，并采取措施。\nWork with internal and external stakeholders, e.g., quality, supply chain, manufacturing, M&ST, Ops Regulatory, China RA, etc., to manage technical related affairs, such as GCE, CMC variation projects, etc.,\n和内外部的利益相关者合作，管理技术相关的事物，比如仿制药一致性评价，CMC的变更项目等。\nAct as the process and regulatory experts to coach quality, technical and manufacturing team to uplift capabilities.\n作为工艺和法规的专家，指导技术、质量和生产团队的能力提升。\nDuring contract manufacturing, conduct on-site supervision of production activities related to AstraZeneca products, ensuring compliance with manufacturing processes, quality standards, and regulatory requirements.\n在委托生产期间，对阿斯利康产品生产相关活动进行现场监督，确保符合生产工艺、质量标准等法规要求。\nDocumentation\n文件\nAuthor technical related SOP, WI, BRP, EBR, Technical Reports, Validation documents, etc., ensure master data is accurate.\n撰写技术相关的SOP，WI, 批记录、电子批记录、技术报告、验证文件等; 确保主数据维护的准确\nAuthor technical training materials and manage product knowledge\n撰写技术培训材料，并管理产品知识。\nProject Management\n项目管理\nLead or support technical project deliverables on time in full, and compliance with AZ PMF, e.g., CMC variation, TT and continuous improvement.\n按照AZ PMF 的要求，领导或支持技术项目的交付，比如CMC variation， 技术转移、持续改进项目等等。\nSHE Responsibility\nSHE责任\nCompliance with AZ code of conduct and SHE requirement.\n符合公司的行为规范和SHE的要求\nTechnical Layout and Artwork Management (Apply to Packaging Engineer)\n技术图纸以及包装设计管理（适用于包装工艺工程师）\nMaintain the current technical layout and create the new technical layouts for new products.\n维护现有的技术图纸，为新产品创建新的技术图纸。\nEnsure the Gazelle system works well in Wuxi site\n确保Gazelle系统在无锡正常运行。\nIssue the specification for the new materials/components\n制定新材料的质量标准\nMBR author\n主批报记录撰写人\nUpdate GMBR, create and update PVL/PMBR \n更新GMBR，创建和更新PVL/PMBR\nDeliver different level training to Wuxi site operators as required.\n按照需要对无锡工厂的操作员工进行不同程度的培训。\nHandle any PAS-X system technical issues during BAU phase.\n在BAU阶段解决PAS-X系统的技术问题。\nEducation, Qualifications, Experience and Capabilities 教育、资质、经验和能力\nEducation, Qualification, Experience\n教育、资质、经验\nUniversity graduate or above\n本科学历/以上\nProfessionalism in the Pharmaceutical knowledge and experience; including production processes, validation, trouble shooting, investigation, and continuous improvement\n专业级的制药知识，包括生产工艺、验证、问题解决、调查和持续改进。\nKnowledge of specific dosage forms.\nOral Solid Dosage knowledge required for formulation lead process engineer;\nsterile/aseptic process and microbiology knowledge required for sterile lead process engineer;\nBlister & bottle packing, etc. knowledge required for packing lead process engineer\n相应区域的专业知识。\n包装主管工艺工程师需具备泡罩包装，瓶包装，西林瓶包装及复合袋包装 等相关知识。\nGMP and regulatory knowledge\nGMP和法规知识\nProfessionalism in process and cleaning validation\n精通工艺验证和清洁验证知识\nExcellent written/Oral English\n英语书写/口语优秀\nHigh level of computer skills\n精通电脑\nStrong statistical knowledge with experience in DoE, limit setting etc.,\n扎实的统计学知识，具备实验设计、限度设定等统计学应用经验\nExperience in PM or Technical Supports of CMC variation and TT.\n在CMC 变更和技术转移项目上，具备项目管理或技术支持的经验\nAt least 1-year experience in the areas of GMBR/PVL/PMBR creation and update\n在GMBR/PVL/PMBR创建和更新方面拥有至少1年的从业经验\nAt least 5 years’ experience in pharmaceutical process\n至少具备5年以上的制药技术工作经验\nHigh level of computer skills\n精通电脑\nStrong statistical knowledge with experience in DoE, limit setting etc.,\n扎实的统计学知识，具备实验设计、限度设定等统计学应用经验\nExperience in PM or Technical Supports of CMC variation and TT.\n在CMC 变更和技术转移项目上，具备项目管理或技术支持的经验\nAt least 1-year experience in the areas of GMBR/PVL/PMBR creation and update\n在GMBR/PVL/PMBR创建和更新方面拥有至少1年的从业经验\nAt least 5 years’ experience in pharmaceutical process\n至少具备5年以上的制药技术工作经验Capabilities\n能力\nRisk Management, analysis and problem solving; \n风险评估、分析和问题解决;\nProject Management; \n项目管理;\nPharmaceutical process with data analysis; \n制剂工艺和数据分析;\nWriting Capability; \n写作能力;\nGXP and Quality Management; \nGXP和质量管理;\nAnalytical method and specification; \n分析方法和质量标准;\nCMC and Regulation; \nCMC和法规;\nFinance evaluation; \n财务分析;\nStrong leadership capability in communication, coordination, influence, judgement, coach and emotion intelligence.\n较强的领导力，包括交流、协作、影响力、判断力、指导和情绪智商。\nAt least level 2 of MBR author skill\n至少达到主批报记录撰写人的2级技能要求。\nDate Posted\n16-Sep-2026Closing Date\n30-Dec-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. 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