Process Support Engineer IV

Category:  Manufacturing
Location: 

Tianjin, Tianjin, CN

   

诺和诺德(中国)制药有限公司天津生产厂是诺和诺德全球唯一的胰岛素耐用注射器械供应商,以及重要的胰岛素制剂与灌装生产基地,在2019年和2020年连续两年荣获Kincentric“最佳雇主”称号。

 

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

 

Qualifications (minimum requirements) 任职资格

Education Background: 教育背景

  • Bachelor in Engineering or other relevant university degree or above;

Professional Experience专业经验:

  • 1 – 3 years pharmaceutical manufacturing experience preferable;
  • Experience from an international company is preferred;
  • Experience in project or quality assurance or pharmaceutical production.
  • Experienced user of MS office (Word, Excel, PowerPoint etc.)
  • Big data knowledge and skill
    • Domain knowledge, Agile toolbox & project Skills, Problem solving & analytical, Math, Stat, modelling, Data & data management, IT infrastructure & technical skills.
  • Experienced in standardizing work
  • Preferable experience with:
    • Regulatory requirements;
    • Formulas and work instructions;
    • Validation requirements;
    • Commissioning, Qualification and Validation of pharmaceutical facilities;
    • Good testing practice;
    • Project management skills;
    • Applied technologies.

Job content工作内容描述

Purpose of the Job职位目标:

Purpose of the Job职位目标:

[Describe key responsibilities that the position contributes to the organization.]

  • Responsible for high compliance standard in DD area. Such as conduct self-inspection.
  • Responsible for quality related documentations.
  • Responsible for CC handling. (Device Only)
  • Play the reviewer role of shop floor training material
  • Support, lead, coach Implement initiatives or projects.
  • Ensure daily support and sparring to production units and support units within the process area.
  • Conduct Durable Device product and component failure analysis-reject analyse.
  • Build big data pipelines through data design, collection, structuring and integration of data sources
  • Others

 Main Job Tasks岗位职责:

[For the key responsibilities indicated above the job tasks should be described in more detail. List the main responsibilities and job tasks that the organization expects this position holder to fulfill (6-8 headlines). It is the Line Manager’s privilege to assign different job tasks according to business needs. The competence house of this position must be attached as appendix of this JD.]

     This position is responsible to support production and process team regarding to compliance related documents and tasks.

  1. Responsible for high compliance standard in DD area. Such as conduct self-inspection.
    1. Conduct self-inspection in DD area and follow up the finding status;
    2. Handling and answering to Internal, Authority audits and others regulatory affairs regarding activities under this position holder responsibility;
    3. Support local, external and supplier audits.

 

  1. Responsible for quality related documentations
    1. Responsible for writing / updating / effective SOPs for the different phases of project and on-going production;
    2. Responsible for personal related DV handling by closely managing throughout the whole investigation cycle, including identification and track of incidents, risk, corrective/preventive actions and effectiveness plans;
    3. Work as the CR coordinator for CR preparation and status monitor
    4. Responsible for handle of Q case and related investigation report to CC.

 

  1. Responsible for CC handling (Device Only)
    1. Work as CC investigator to drive CC related issues, test (Test materials applying, Physical Test/Equipment test, CC samples/Test report archiving) and prepare the CC report;
    2. CC case coordination and action follow up cross functionally;
    3. Communication among patient, marketing, product maintenance, manufacturing, QA, DMD/CCC and TFDA;
    4. CC Error code and SOP management (Draft/review/PC/updating CC);
    5. CC trend analysis and reporting for different purposes (CC weekly report/ QMR report related to CC/ Audit report);
    6. Work as CC trainer to train production on quality topics and CC handling to PS engineers (JTP setting up).

 

  1. Play the reviewer role of shop floor training material
    1. Review the content of shop floor training material and test paper correlates with related SOPs.

 

  1. Support, lead, coach Implement initiatives or projects.
    1. Support project manager on the routine tasks
  • Follow up on the performance of associates and agreed deadlines;
  • Prepare and follow up the document list and open task list;
    1. Lead improvement initiatives or project correlates with LEAN logic & approach.
      •    Organizing and leading requirement analysis, data collection, documentation and other productivity improvement related meetings with cross-functional teams and stakeholders at all levels.
      • Drive implement on the compliance signals.
    2. Coach improvement project.

 

  1. Ensure daily support and sparring to production units and support units within the process area
    1. Ensure that efficient process KPIs are defined and followed up upon;
    2. Drive problem solving/event response to local problems and comprehensive NCs;
    3. Identify improvement opportunities and implement locally with documented benefit and drive local improvement projects;
    4. Own local standards. Responsible for developing and maintaining local procedures and standards within the process, including local JTP’s and training material;
    5. When local or global standards are changed ensure that relevant training documents are updated and initiate training of relevant employees by informing line of business about new standard;
    6. Ensure that SOP’s and standards within the process are effective by evaluating how they are used and work in praxis (Process Confirmation);
    7. Ensure compliance to external regulations;
    8. Be “one point of entry” to the process regarding solutions.

 

  1.  Conduct Durable Device product and component failure analysis.
    1. Handle reject samples with compliance to internal requirements.
    2. Carry out preliminary failure analysis based on correct understanding of product knowledge educated by product specialist and defined procedures. Support related deviation and project handling
    3. Collect and maintain related data, monitor product performance with trending of data in close cooperation with product specialist
    4. Timely react to the out of control limit of rejects by providing fast feedback from preliminary failure analysis to the stakeholder
    5. Report abnormal from failure analysis to product specialist and line of business.
    6. Support additional failure investigation tasks. For example, collect batch information, execute manual test on finished devices to verify product performance, collect component and device samples for test or measurement.
    7. Department AA

 

  1.  Build big data pipelines through data design, collection, structuring and integration of data sources
    1. Setup and maintain architecture of date collection and reporting system for DV investigation, production issue, KAIZEN and other business needs.
    2. Design and maintain the visualization function for electronic and physical performance management systems.
    3. Integrate data source into ADA and related database system for reporting functions.
    4. Participate the data related manufactory intelligence projects as data engineer.

 

  1. Others
    1. As an employee at STJ contributes to the EHS work in the department as relevant from their positions. The tasks and duties as described in enclosure 2 of EHS manual (QBIQ doc. No. 044249)
    2. Other tasks will be assigned in accordance with business requirements.                                                                                                                                                    

诺和诺德志在成为世界上最卓越的公司之一。我们坚信,怀抱不同观点、来自不同文化背景的人才相聚于此,是成就卓越企业的关键。因此,我们致力于倡导包容性,让我们的员工、我们服务的患者以及我们置身的社区能够充分拥抱多样性。我们承诺在招聘流程中确保包容性,并为所有求职者提供平等的职业机会。同时,我们热衷于根据不同工作职责和业务需求来探索灵活工作的模式。

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.