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Senior Process Engineer
15-27K/月山东省-青岛/本科及以上/3-5年
李先生一周前来过
杭州锐致商务咨询有限公司
职位详情
任职要求：
Project phase (2024-2028)
· Ensure pMDI site smoothly startup for BAU from technical and process perspectives.
· Fully involved in production line design, construction, qualification, and validation activities and deliver Qingdao PMDI site as autonomous and smart factory.
· Ensure technical documentation, SOP/WI setup ready for BAU and meet GMP/SHE requirement, improve AZSS maturity, process robustness, production year and other SQSCP KPIs.
· Build digital solutions and data analysis capability.
· Ensure SAP/MES master data, BOM recipe and PV setup ready for BAU and continuous improvements.
· Support manager on validation, cleaning strategy and implementation, CPV etc activities.
· Manage TT successfully.
BAU phase (2028 onwards)
· Provide technical support for pMDI products, including investigation and correction of process-related problems and deviations from standards.
· Responsible for identifying and executing projects to reduce cost, improve product quality, improve yield, and reduce materials usage.
· Design and execute process qualifications and validations for approved changes.
· Initiate and deliver pMDI related change proposals in compliance with GMP/SHE and AZ standards.
· Edit, update, review and approve technical related procedures to ensure correct content and in compliance with GMP.
· Serve as SME for technical projects affecting pMDI operation during internal audits and regulatory inspections.
· Lead TT and implementation of new technologies, equipments and processes from TOSI and other sites
· Enhance quality and effectiveness of manufacturing systems related to pMDI products as product owner.
· Responsible for providing pharmaceutical process support to new and existing pMDI products and processes.
· Develop product/process knowledge and provide training.
· Contribute to URS and participants in FAT/SAT/PQ/PV.
· Conduct statistical process control and process capability analysis with digital and lean tools.
· Investigate and conduct PPS and RCA of unexpected trends or results and continuously improve on process reliability and robustness.
· Autonomous site vision contribution from technical and data analysis perspectives.
· Execute work in compliance with GMP, AZ policies, SOP and WI
SAP/System master data owner including BOM, recipe, PV setup and maintain.
岗位职责：
Project phase (2024-2028)
· Ensure pMDI site smoothly startup for BAU from technical and process perspectives.
· Fully involved in production line design, construction, qualification, and validation activities and deliver Qingdao PMDI site as autonomous and smart factory.
· Ensure technical documentation, SOP/WI setup ready for BAU and meet GMP/SHE requirement, improve AZSS maturity, process robustness, production year and other SQSCP KPIs.
· Build digital solutions and data analysis capability.
· Ensure SAP/MES master data, BOM recipe and PV setup ready for BAU and continuous improvements.
· Support manager on validation, cleaning strategy and implementation, CPV etc activities.
· Manage TT successfully.
BAU phase (2028 onwards)
· Provide technical support for pMDI products, including investigation and correction of process-related problems and deviations from standards.
· Responsible for identifying and executing projects to reduce cost, improve product quality, improve yield, and reduce materials usage.
· Design and execute process qualifications and validations for approved changes.
· Initiate and deliver pMDI related change proposals in compliance with GMP/SHE and AZ standards.
· Edit, update, review and approve technical related procedures to ensure correct content and in compliance with GMP.
· Serve as SME for technical projects affecting pMDI operation during internal audits and regulatory inspections.
· Lead TT and implementation of new technologies, equipments and processes from TOSI and other sites
· Enhance quality and effectiveness of manufacturing systems related to pMDI products as product owner.
· Responsible for providing pharmaceutical process support to new and existing pMDI products and processes.
· Develop product/process knowledge and provide training.
· Contribute to URS and participants in FAT/SAT/PQ/PV.
· Conduct statistical process control and process capability analysis with digital and lean tools.
· Investigate and conduct PPS and RCA of unexpected trends or results and continuously improve on process reliability and robustness.
· Autonomous site vision contribution from technical and data analysis perspectives.
· Execute work in compliance with GMP, AZ policies, SOP and WI
SAP/System master data owner including BOM, recipe, PV setup and maintain.
Project phase (2024-2028)
· Ensure pMDI site smoothly startup for BAU from technical and process perspectives.
· Fully involved in production line design, construction, qualification, and validation activities and deliver Qingdao PMDI site as autonomous and smart factory.
· Ensure technical documentation, SOP/WI setup ready for BAU and meet GMP/SHE requirement, improve AZSS maturity, process robustness, production year and other SQSCP KPIs.
· Build digital solutions and data analysis capability.
· Ensure SAP/MES master data, BOM recipe and PV setup ready for BAU and continuous improvements.
· Support manager on validation, cleaning strategy and implementation, CPV etc activities.
· Manage TT successfully.
BAU phase (2028 onwards)
· Provide technical support for pMDI products, including investigation and correction of process-related problems and deviations from standards.
· Responsible for identifying and executing projects to reduce cost, improve product quality, improve yield, and reduce materials usage.
· Design and execute process qualifications and validations for approved changes.
· Initiate and deliver pMDI related change proposals in compliance with GMP/SHE and AZ standards.
· Edit, update, review and approve technical related procedures to ensure correct content and in compliance with GMP.
· Serve as SME for technical projects affecting pMDI operation during internal audits and regulatory inspections.
· Lead TT and implementation of new technologies, equipments and processes from TOSI and other sites
· Enhance quality and effectiveness of manufacturing systems related to pMDI products as product owner.
· Responsible for providing pharmaceutical process support to new and existing pMDI products and processes.
· Develop product/process knowledge and provide training.
· Contribute to URS and participants in FAT/SAT/PQ/PV.
· Conduct statistical process control and process capability analysis with digital and lean tools.
· Investigate and conduct PPS and RCA of unexpected trends or results and continuously improve on process reliability and robustness.
· Autonomous site vision contribution from technical and data analysis perspectives.
· Execute work in compliance with GMP, AZ policies, SOP and WI
SAP/System master data owner including BOM, recipe, PV setup and maintain.
岗位职责：
Project phase (2024-2028)
· Ensure pMDI site smoothly startup for BAU from technical and process perspectives.
· Fully involved in production line design, construction, qualification, and validation activities and deliver Qingdao PMDI site as autonomous and smart factory.
· Ensure technical documentation, SOP/WI setup ready for BAU and meet GMP/SHE requirement, improve AZSS maturity, process robustness, production year and other SQSCP KPIs.
· Build digital solutions and data analysis capability.
· Ensure SAP/MES master data, BOM recipe and PV setup ready for BAU and continuous improvements.
· Support manager on validation, cleaning strategy and implementation, CPV etc activities.
· Manage TT successfully.
BAU phase (2028 onwards)
· Provide technical support for pMDI products, including investigation and correction of process-related problems and deviations from standards.
· Responsible for identifying and executing projects to reduce cost, improve product quality, improve yield, and reduce materials usage.
· Design and execute process qualifications and validations for approved changes.
· Initiate and deliver pMDI related change proposals in compliance with GMP/SHE and AZ standards.
· Edit, update, review and approve technical related procedures to ensure correct content and in compliance with GMP.
· Serve as SME for technical projects affecting pMDI operation during internal audits and regulatory inspections.
· Lead TT and implementation of new technologies, equipments and processes from TOSI and other sites
· Enhance quality and effectiveness of manufacturing systems related to pMDI products as product owner.
· Responsible for providing pharmaceutical process support to new and existing pMDI products and processes.
· Develop product/process knowledge and provide training.
· Contribute to URS and participants in FAT/SAT/PQ/PV.
· Conduct statistical process control and process capability analysis with digital and lean tools.
· Investigate and conduct PPS and RCA of unexpected trends or results and continuously improve on process reliability and robustness.
· Autonomous site vision contribution from technical and data analysis perspectives.
· Execute work in compliance with GMP, AZ policies, SOP and WI
SAP/System master data owner including BOM, recipe, PV setup and maintain.
任职要求
无
薪资结构
无
其他信息
职能类别：SFE
职位性质：全职
招聘人数：1
工作地点：
- 1 山东省-青岛
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公司信息
某医药公司
- 上海
- 1000-9999人
- 生物制药
- 外企
- 不需要融资
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