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Process Engineer Device and Packaging Development

Engineering
Basel
English

                   Process Engineer ( packaging processes) Do you have experience in Process engineering or packaging processes?  Do you want to be a part of a world-leading medical device and pharma company?  Then you should read the following lines! Our client, based in ZUG   is looking for a Process Engineer who has experience in packaging processes,  if you are the right fit don’t hesitate to apply. The perfect candidate: We are looking for a young talent who is keen and eager to learn new things from a manufacturing/engineering part and who has already some experience in this industry. The perfect candidate has a technical flair and hands-on experience in semi- or fully-automated assembly and packaging processes. Tasks & Responsibilities • Support design transfer projects for portfolio products within the agreed timelines and quality requirements.
• Author scientific reports, memos, and rationales related to design transfer, risk management, and control strategy documentation.
• Plan, design, execute, and document testing within the framework of process design and combination product verification activities
• Collaborate effectively with broad cross-functional internal and external teams in developing strategies and concepts for the manufacturing of medical devices and combination products.
• Ensure the qualification and validation of processes and equipment in collaboration with internal V&V specialists.
• your kledge of the regulatory landscape to ensure standard-compliant designs (e.g. ISO 13485, 21CFR820, ISO14971, and 21 CFR 820.30).
 Must Haves: • Min. Bachelor's degree in engineering or related discipline 
• Min. 2-5 years of experience in product commercialization or process engineering /industrialization within the pharmaceutical or medical device industry.
• Hands-on kledge of product industrialization using semi- or fully-automated assembly and packaging processes and Sound understanding of Design Control and Design Transfer Activities 
• Broad experience in manufacturing technologies for low and high-volume applications (e.g. assembly, packaging, injection molding, machining, marking, printing, gluing, sealing, welding)  • Technical/ Digital Flair 
• German and English fluent needed
• Person that can learn quickly and is keen to broaden his or her kledge
• Enthusiastic team player
• Communication skills Nice to Haves: • Experience with ISO 13485, 21CFR820, ISO14971, and 21 CFR 820.30 regulations is a plus
• Experience in an equipment supplier for a pharmaceutical company or CMO // Medical Device environment
• Experience in working in a project environment, preferred experience in project management
• Experience of working in pharma or other closely-regulated environments is preferred