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AstraZeneca

Global pharmaceutical company developing prescription medicines

Senior Lead Engineer - Process

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeWuxi, Jiangsu, ChinaNo salary listedIn-person

About the Job

Requirements

  • A university degree or higher is required.
  • Professional pharmaceutical knowledge and experience, including production processes, validation, troubleshooting, investigation, and continuous improvement, are required.
  • Knowledge of the relevant dosage form is required. Formulation senior process engineers require oral solid dosage and continuous direct compression knowledge; sterile process engineers require sterile or aseptic process and microbiology knowledge; packing process engineers require blister and bottle packing knowledge.
  • Knowledge of Good Manufacturing Practice and regulatory requirements is required.
  • Professional knowledge of process and cleaning validation is required.
  • Excellent written and spoken English is required.
  • A high level of computer skills is required.
  • Strong statistical knowledge, including experience with Design of Experiments and limit setting, is required.
  • Experience in project management, technical support, or technical transfer is required.
  • At least one year of experience creating and updating GMBR, PVL, or PMBR documents is required.
  • At least three years of experience in pharmaceutical process work is required.

Responsibilities

  • Collaborate with cross-functional teams, global subject matter experts, stakeholders, and external parties to deliver CDC and PP Packing stream projects and support autonomous manufacturing and zero-carbon factory objectives.
  • Introduce new equipment, processes, and technologies according to project strategy and plans to deliver formulation and packing projects on time.
  • Lead technical project deliverables, including material source changes and technical transfers.
  • Author production documents, including batch sheets, electronic batch production records, forms, standard operating procedures, change documents, and validation protocols and reports.
  • Design and conduct qualification, process validation, and cleaning validation.
  • Resolve complex technical problems and conduct investigations to support process robustness.
  • Drive continuous improvement of process robustness.
  • Own product and process activities, including critical process parameters, critical material attributes, critical quality attributes, and continued process verification.
  • Coach process, manufacturing, and quality teams to improve their technical capabilities.
  • Work with internal and external stakeholders to manage technical matters.
  • Enable project stream deliverables to plan, including facility and process design, supplier selection, factory acceptance testing, site acceptance testing, qualification, and handover.
  • Work with stakeholders to achieve defined project targets.
  • Support stream leaders in project management under the AZ PMF framework, including reporting, escalation, communication, and change management.
  • Communicate project execution progress to client teams.
  • Represent the technical function in risk-based impact assessments for change controls.
  • Update the site validation master plan and ensure visibility of validation plan execution status across the site.
  • Coordinate implementation of site quality system requirements.
  • Train site personnel on validation concepts and local validation document requirements as requested.
  • Draft validation master plans and validation plans as appropriate.
  • Review and approve validation documents as appropriate.
  • Represent validation to facilitate validation work across projects.
  • Conduct risk-based validation assessments for change controls as the validation representative.
  • Generate and maintain validation document templates for each validation type.
  • Generate and maintain validation training materials.
  • Manage qualification- and validation-related change activities, including supply switchovers and validation batch release management.
  • Provide expert guidance and advice in specialist areas, promote collaboration and knowledge sharing among project teams, and support the development and maintenance of project management skills, processes, and capabilities across the site and operations.
  • Use lean concepts and tools in project management.
  • Investigate issues encountered during routine production and conduct technical evaluations and studies, including Design of Experiments, to improve process robustness.
  • Own products and processes by conducting continued process verification, identifying improvement opportunities and risks, and taking proactive actions.
  • Work with internal and external stakeholders, including quality, supply chain, manufacturing, M&ST, operations regulatory, and China regulatory affairs, to manage technical matters such as generic consistency evaluation and CMC variation projects.
  • Act as a process and regulatory expert and coach quality, technical, and manufacturing teams to improve their capabilities.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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