Maintenance Area Specialist

Education Background:
Bachelor Degree or Master Degree in technical field or industry equivalent experience or similar education background.
Education/training of cGMP regulation.
过cGMP的培训。
• Fluent in written and reading English.
Professional Experience专业经验:
Demonstration of 8 years or above subject matter expertise in aseptic production technical area, in pharmaceutical industry or in life science industry.
有8年以上在无菌生产，或是生命科学技术领域的工作经验
• In-depth knowledge & experience in overall DFP aseptic production equipment & process flow aspects, including following high-speed & automated systems:
Filling, Formulation, W&S, Inspection, remote control system design/research/development & application, material automatic transformation system design/ research/development & application, Equipment AI, Big Data system research/development & application, equipment & system validation, etc.
Proven in-depth expertise & primary leadership in mentoring/coaching/development, design & change management, planning/organizing, managing execution, and revising the work plan for complex problems solved by task force from cross functional/cross areas/cross sites.
Rich experience driving process design/improvements using systematic methodologies; lean and six sigma skills are strongly preferred.
Working independently in cross functional team environment, while handing specialist tasks of high complexity which critical contribute to Area/Site/DFP business target & strategy.
Purpose of the Job职位目标:
AP Technical Support specialist is overall responsible for relevant automatic & intelligent system design/research/development/implementation & improvement of AP all equipment & process, also responsible for managing projects to ensure delivering according to project plan.
And also need to cooperate & coordinate with global supplier for technical innovation development, collaboration & exhibition, etc.
AP Technical Support Specialist need to involve AP & STJ strategy setup & execution, to meet STJ & DFP, PS business target & long-term strategy development.
AP Technical Support Specialist will on behalf of STJ AP to involve or lead cross site/DFP/PS high-level collaboration of specialist group, for cross site net work & sharing platform setup & driving, which play most key role in technical innovation & strategy development of whole DFP, even PS.
The AP Technical Support Specialist is critically impact & contribute for the following indicators of all AP core equipment & process flow - W&S, Formulation, Filling, inspection:
Line Capacity & Stability生产线能力及稳定性的提升
• Scrap Rate & First Pass Yield提出率的降低以及首件通过率
• Spare Parts Control 备件控制
• Green Reality Development & Roadmap Green Reality项目路线图的制定及实施
• Hoshin_Kanri 战略部署
• Product Transfer产品转移
• MTBR/MTTR
• OEE3 & L/H Level
• Work order completion工单完成率
• Validation验证
• Compliance合规性 Main Job Tasks 主要工作任务:
Responsible for providing aseptic technical expertise on equipment & process flow.
Responsible for resolving technical needs and driving improvement opportunities.
Responsible for assisting technical by providing non-conformity support.
持NC处理促进技术改进。
• Responsible for coaching and leading investigations for technical-related issues.
Acts as a maintenance advocate, coordinating daily schedule, removing barriers and enabling maintenance to run optimally.
Serves as coach and technical mentor for Equipment & Process Owner, maintenance teams and relevant process teams.
Real time Coaching/mentoring of engineers/professionals in maintenance & technical aspects:
o FIT/MWD 故障调查和维修工作说明.
o Preventative and Predictive maintenance standards 预防性和预见性维系标准 o Maintenance role cards 维修职责卡.
o Technical systematic problem solving 解决技术问题 o Execute process confirmation of maintenance standards used on shift and work with maintenance & process team to find ideas to proactively improve quality and compliance 做维修标准在工作中执行情况的过程确认，前瞻性地改进质量和合规性 o Coordinate relevant technical & process training 协调相关的技术&工艺培训.
Ensure continuous development of aseptic production area quality and principles by systematic collection of knowledge and standardization of technique and validation and supported by cLEAN® tools:
cLEAN ®工具，确保无菌产区质量和原则的不断发展
• Ensure “Knowledge exchange” across departments, projects and sites 确保跨部门、跨项目、跨工厂的"知识交流"。
• Develop and update relevant tools, methodologies and training materials 开发和更新相关工具、方法和培训材料。
• Stay updated on latest developments within technique, validation and Lean principles from internal and external sources.
Automatic system & equipment design/research & development 自动化系统&设备设计/研发
• Lead or participation in STJ project group or DFP project groups of projects which will be transferred to STJ.
或DFP项目组.
Lead or Participation in mechanical & automation system design robustness challenge meeting, in STJ or DFP.
STJ 或 DFP 中领导或参与机械和自动化系统设计稳健性挑战会议
• Recommendation & management of specifications optimization.
Design of test setups.
Lead or participation in production maturing, optimization & development activities.
Planning and follow-up of activities with subcontractors, consultants and designers.
Take the role of Subject Matter Expert.
o Present process during audit & inspection.
Guide audit tour on shop floor.
Coordinate with department fulfil audit request.
Support to answer questions during audit and inspection.
o Ensure global SOP & GMP requirements implementation.
Review documentation and do gap analysis for SOP and reports to ensure compliance.
部SOP及GMP要求的落实。审查文档并为SOP和报告进行间隙分析，以确保合规性。 o Coaching on compliance and train engineers on process knowledge.
Identify compliance gaps in responsible process, share finding s and new regulation requirements.
o Review NC/CR and give inputs.
Provide professional idea to continuous improvement.
Share best practice across sites.
查NC/CR并提供建议。提供不断改进的专业理念。跨工厂共享最佳实践
• Coach/mentor process coordinators, engineers, and technicians in resolution of MTTR, MTBF, ramp-up following PM1, function BCO time, Ramp-up, and maintenance/technical.
MTTR、MTBF、PM 方面的提升。
• Coach/mentor/teach process coordinators, engineers, and technicians in reliability management system activities.
Execute on shift maintenance plan, review and close work orders.
Quickly flexes to changes in the work environment and is able to prioritize business needs with grace and ease.
Looks for common goals.
Demonstrates behavior consistent with “for me to win the team must win” beliefs.
Demonstrates a disciplined, systematic approach to problem solving that is based on data and facts.
Builds strong working relationships within the team and with other departments
• Observes and enforces all safety and environmental requirements
• Models the NNWay
• Performs other duties as required 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.
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