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Packaging Engineer
Your role:
The Packaging Engineer is responsible for the development, validation, and implementation of innovative sterile barrier packaging solutions for Cell Therapy hardware and consumable products. Cell Therapy products include a variety of highly differentiated configurations and sizes of pharmaceutical bioprocessing and manufacturing equipment manufactured in a Class 6 and 7 cleanrooms. This is a unique, challenging, and one of a kind opportunity for someone willing to step up and showcase their skills, innovation, and ingenuity by developing creative packaging solutions for hardware and sterile barrier for a diverse and rapidly expanding product line.
Your responsibilities:
• Develop & implement a long-term packaging strategy for the equipment and Single Use product line taking into consideration the entire work stream from manufacturing to customer use, applications, and customer expectations.
• Develop the tools and packaging materials required to implement predicting packaging for Single Use products.
• Collaborate with R&D to develop packaging solutions for new products in the early stages of development.
• Act as the key resource for packaging technical expertise for Single Use Assemblies and provide guidance to ensure packaging systems comply with all relevant internal and external customer and quality requirements.
• Collaborate with Manufacturing Engineering, Operations, Quality, R&D, Product Management, and Sales to identify and implement opportunities to resolve various existing challenges associated with the packaging of MilliporeSigma Cell Therapy products.
• Develop and Author Risk Assessments, User Requirement Specifications, Standard Operational Procedures, Validation Protocols/Reports, Purchase Specifications, and Customer Summary Reports associated with packaging.
Who you are:
The ideal candidate will view this role as a partnership with the hiring manager, the engineering leadership team, and the members of the Product Engineering Team. Not deterred by confrontation, but flexible and open to new ideas, tools, and the ability to work in a high paced and ever changing work environment. Highly adaptable, a problem solver, innovator, and strong advocate for achieving strategic initiatives.
• Bachelor's Degree in Packaging Engineering (preferred), Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or similarly related engineering field
• 3+ years of Packaging Engineering experience in the design, development, and implementation of sterile packaging (including new materials and processes), preferably in pharmaceutical or medical device packaging
• Excellent collaboration and communication skills working with suppliers and other intercompany departments
• Experience with ASTM and ISTA standards regarding sterile packaging developing and transit simulation/ship testing
• SolidWorks experience desired
• Knowledge of manufacturing concepts; GMP/GEP knowledge
• Strong program/project management skills
• Proficient in MS Word, Excel, and PowerPoint
