Senior Process Engineer

Location: Qingdao Site

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.

AstraZeneca 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. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.