Site Technical Manager

Working location: Permanent Qingdao from 2024 q2, prior, in Taizhou

Responsibilities:

Project phase (2024-2028)

·Design, setup and develop technical team to support project progress.

·Fully involved in project design, construction, qualification, and validation activities and deliver Qingdao PMDI site as autonomous and smart factory.

·Setup technical transfer process and qualify/validate the facility/equipment based on project schedule and scope.

·Setup cleaning strategy and implementation.

·Ensure site qualification and validation strategy to align with site business goals.

·Ensure technical documentation, SOP/WI setup ready for BAU and meeting GMP/SHE requirement and improve AZSS maturity and improve technical expertise for the team.

·Digital solutions and data analysis capability buildup.

BAU phase (2028 onwards)

·Develop and manage technical services resources, programs, and systems to support the needs of the business while ensuring robust compliance.

·Provide first line technical expertise and support to PPS of product and process issues.

·Accountable for technical system and process compliance such as Change control, deviation, CAPA’s activities management and timely resolution.

·Perform technical assessments for changes proposals to ensure SHE, regulatory compliance, GMP compliance, and manufacturability improvements.

·Understand, analyze and agree targets for pMDI product performance such as manufacturing process robustness and yield improvement.

·Accountable for the evaluation and utilization of new technology for pMDI processes optimization.

·Accountable for MMM reviews, approval and change controls.

·Accountable for NPI and all related process such as TT, validation activities and cleaning strategy at stie.

·Ensure validation program timely delivery and resolution of problems to ensure minimum costs prevent operation delays.

·Accountable CPV process and all related documentation review and approval and annual reporting system.

·Conduct or coordinate the execution of in-depth statistical analyses as required for submission purpose, site investigations or special projects.

·Oversee and monitor site statistical business needs to align autonomous site vision.

·SAP and related system master data setup such as BOM, recipe and PV etc.

·Build up lean culture in technical team by practicing lean/digital/automation solutions and business benefit realized.

Continuous improve technical expertise and process robustness and contribute to autonomous factory.

Requirements:

·Bachelor’s degree or above, major in engineering or science or pharm related.

·Excellent communication and influence in English.

·Data analysis and interpretation capability.

·Adaptability, continuous learning and learning agility.

·Advanced product and technical expertise.

·Above 10 years professional work experience with a minimum 5 years in technical environment

·Have full TT and NPI experience.

·Fully competency in SAP and MES systems.

·Have project or new site startup related experience.

·Strong business acumen in manufacturing and pharmaceutical industry including GMP and SHE requirements and the applicability to pharmaceuticals.

·Strong expertise on pMDI processes including formulation, filling, assembly and packing.

·Good knowledge in propellent such as HFA/HFO etc.

·Experience of global NPI projects and ability to manage multiple projects at once.

·Experience in autonomous/smart factory.

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.