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Process R&D Engineer

Location: Ladkrabang
Salary: Negotiable

Main duties and responsibilities:
• Developing and validating the processes needed to the manufacture of the products.
• Suggest process improvement bearing in mind scale up and industrialization constraints
• Propose and define technical solutions with external suppliers and internal resources (maintenance, production) for process definition and optimization
• Setting up of new manufacturing process:
• Identification of key process parameters and operating windows prior to OQ phase, in an 
exhaustive and systematic approach based on product/process risk analysis (FMEA)
• Participate to the preparation of production documents, working standards and technical 
documentation (e.g. work instructions, test instructions, trials reports….). To generate, record and report accurate experimental data.
• To assess the quality and validity of data generated and draw conclusions from that data ensuring accurate reports are written
• Support site related activities such as installation and commissioning of equipment (IQ)
• Follow and run validation and qualifications protocols (IQ/OQ/PQ) defined by R&D department:
• Raw material preparation
• Equipment start-up
• Products traceability
• Production and QC training
• Ensure that production is done, during qualifications runs, according to the established 
procedures and standards
• Identify with maintenance departments Preventive Maintenance (PM) items
• Ensure the equipment are in good conditions and calibrated
• Participate to risk management activities (P-FMEA)
 

Knowledge, skills:
• Bachelor or Master’s in engineering degree with a major in in mechanical engineering
• Preferably 3 years of successful experience in process development and process validation in the 

medical device, cosmetic or pharma industry
• Strong interpersonal, communications skills and ability to work cross functionally with 
production, quality, maintenance and industrialization department, are key to success in this role
• Ability to work on the production floor (process set-up and adjustments)
• Knowledge of problem-solving methods
• Fluent in Thai with good command of English, both written and spoken is mandatory.
• Highly responsible, dependable, with good sense of ethic
• Familiar with MS Office.
• Diligent, meticulous, attention to the details
• Willingness and ability to learn fast
• Some knowledge of the EU and US regulations related to the development of Medical Devicesand its documentation (ISO 13485, Risk Management, Design Control, Traceability…) is a plus
• Knowledge of statistical (e.g. capability study) and Design of Experiment (DOE, Minitab) is a plus

• หางานวิศวกร


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