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.