1) Main tasks:
• Withminimal guidance and supervision of the Manager, coordinate all efforts formajor design and development projects from concept through release.
• Leadin the conceptualization, initiation, development and implementation of new andimproved packages and processes including: design generation, prototypedevelopment, engineering specifications, mold and machinery qualification,functionality and quality testing, and technology transfer. Will participate,and sometimes lead, multi-functional teams on these projects;
• Developand establish detailed engineering specifications for packages, processes,and/or equipment to ensure product function and cost effective manufacturing;including 3D CAD models, detailed drawings, specifications, inspections andtest methods, manufacturing procedures, sterilization procedures, and materialmanagement documents.
• ApplyDesign Control regulations in product development.
• Provideefficient and timely documentation and/or transfer of manufacturing andengineering technologies.
• Writetest protocols and provide test data to demonstrate feasibility of packagingand products.
• Writetest reports.
• Developcustom equipment to support small scale product assembly and testing.
• Interfaceregularly with vendors and consultants.
• Supportline manager and other project managers with Project Management techniques.Responsible for developing and executing project plans.
• Ensureeffective utilization of the Packaging Laboratory to coordinate and execute labevaluations, quality control procedures and test method development. Support Divisional needs in identifyingquality defects and driving resolution
• Implementstandardization and simplification programs, and margin improvement projects
• Interfacewith cross functions to ensure project meets agreed upon goals. Continuouslyassess and communicate project results vs. goals and take corrective actionwhen required
• Collaboratewith Procurement to develop and help negotiate local, regional, or globalcontracts with suppliers. Evaluate andcoordinate supplier’s activity related to on-going projects
• Understand,interpret and refine package testing procedures and standards to support theeffective design, validation, and implementation of new packages and packagingtechnology. Provide meaningfulexplanations and forward actions to appropriate Division/Subsidiary personnel
• Identifyand provide rationale for funds needed to successfully deliver project goals
• Writeand present technical and business summaries for both technical and non-technicalpersonnel
• Buildcompetitive advantage by identifying, evaluating, and championing technicaladvancements, design trends and innovations in packaging. Stay aware of supplier and competitor newdevelopments, and highlight to appropriate management as needed
• Develop,justify and execute capital projects related to packaging (i.e.molds/machinery)
• Identifynew platform/product opportunities that provide high end-user value
• Seekout and leverage technology to bring consumer value
• Developand utilize a broad network of technical resources to expedite projectcompletion
• Offerguidance, support and mentorship to junior and senior level engineers.
• Otherduties as assigned.
The functionincumbent reports to: Organizational unit:
Important internalinterfaces: Important externalinterfaces:
• Differentdepartments within the company
• GMQAP sites Please list cooperation withimportant external companies, agencies, authorities etc.
The functionincumbent is represented by: Thefunction incumbent represents:
Technical Leader,CCS Technical Leader, Sr. Engineer,CCS
Please listdistinguishing qualitative and quantitative features by means of whichperformance in the position can be measured.
• Takesownership of assigned projects and provides timely and quality completion ofproject deliverables, goals, and milestones.
• Protocolshave thorough study designs that meet project objectives and regulatoryrequirements.
• Designand development documentation (test records / reports / design history files /etc.) are high quality and in compliance with company policies.
• Interfaceswith cross functions to ensure project goals are achieved.
• Promotesinnovation and builds competitive advantage for products and technicalcapabilities of the Company.
• Servesas a mentor / leader for junior and senior level engineers and cross-functionalteam members.
Qualifications,experience, know-how and skills critical for success*
1) Requiredtraining and education:
• B.S.,M.S. or Ph.D. Degree in Packaging, Engineering or Material Science.
2) Requiredprofessional experience (in years):
• B.S.with at least 10 years of relevant experience, M.S. with at least 5 years, orPhD with at least 3 years of relevant experience.
• Experiencein pharmaceutical packaging design is desirable.
3) Importantpersonal qualities:
• Previousexperience in a multi-national company
• Experiencein the pharmaceutical and/or medical device industry, and familiarity with thedesign control process.
• Experiencecoordinating packaging development project with cross functions.
• Experiencein package testing and with package specifications
• Experiencewith Logistics and Operations and how they relate to packaging design
• Experiencewith sustainable packaging design methods and materials
4) Otherspecialized knowledge:
• Understandingand experience with local and international testing standards.
• Anunderstanding of various packaging materials tooling design and schedulesdesirable
• Fluentin both spoken and written English and Chinese.
c) IT skills
• PackagingCAD design experience using both 2D and 3D applications
• Familiarwith Dialysis products
5 ) Specialpersonal requirements:
• Candidatemust be able to work independently as well as under direction whilecontributing knowledge and experience to projects.
• Mustbe self-motivated, possess good interpersonal skills, and the ability to handlea wide variety of work assignments while meeting tight timelines.