TS Senior Process Engineer
- Ensure pMDI site smoothly startup for BAU from technical and process perspective
- 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 meeting GMP/SHE requirement and improve AZSS maturity and improve process robustness and production yield and other SQSCP KPI for the team
- Digital solutions and data analysis capability buildup
- Ensure SAP/MES master data, BOM recipe and PV setup ready for BAU and continuous improvement
- Support manager on validation, cleaning strategy and implementation, CPV etc activities
- Manage TT successfully
- Provides 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
- Collaborates with PET,Facility and Utility, Automation,and Quality to optimize productivity, yield, product quality and supply reliability
- Designs and executes process qualifications and validations for approved changes
- Initiate pMDI related change proposals as required and delivered to compliance with GMP/SHE and AZ standards
- Authors, updates, reviews and approves area procedures to ensure correct content and compliance with GMP
- Serves as SME for technical projects affecting pMDI operation during internal audits and regulatory inspections
- Leads TT and implementation of new technologies, equipment and processes from TOSI and other sites such as AZDP
- Enhance quality and effectiveness of manufacturing systems related to pMDI products as product owner. This includes the design, execution and evaluation of experimental plans to ascertain the required process capabilities, specifications and robustness.
- Responsible for providing pharmaceutical process support to new and existing pMDI products and processes
- Trains and mentors team members
- Develop product/process knowledge
- Leads or involve in TT activities
- Contributes to URS and participants in FAT/SAT/PQ/PV
- Conducts statistical process control and process capability analysis with digital and lean tools
- Investigates and conducts PPS and RCA of unexpected trends or results and continuous improve on process reliability and robustness
- Autonomous site vision contribution from technical and data analysis perspective
- Maintains a sate workplace to compliant with SHE requirement
- Executes 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.
