Packaging Design Engineer (100% Remote)

Company: Aerotek
Location: Rockville
Posted on: January 15, 2022

Job Description:

Description:The Packaging Engineer will be responsible for technical leadership in the design, development, testing and validation of product packaging solutions for sterile combination products.They will be responsible for successful execution of engineering activities and involved in development and validation of existing and new packaging designs and processes for the transfer to manufacturing and launch of new products for the CNS TAL & Devices R&D Unit.They will lead packaging engineering activities and serve as packaging technical lead on one or more projects. They will design and develop functional, sterile packaging systems and oversee the engineering work of multiple contractors including design firms, laboratories, and manufacturing organizations.Skills:ISO 11607, packaging design, Solidworks, injection systems, AutoCAD civil 3d, ISO 14971, ICH Q9Top Skills Details:ISO 11607, Packaging Design, Solidworks, Injection SystemsAdditional Skills & Qualifications:Candidate must possess:A minimum of a Bachelor's or advanced degree in the field of Engineering (or similar discipline). Masters degree preferred.5+ years of experience in pharmaceutical or medical device packaging design and development. Multiple successful product launches preferred.Experience in design, development and qualification of sterile packaging systems for sterile combination products or medical devices is essential.Experience in design of packaging systems for ethylene oxide terminal sterilization process is preferredExperience in the development of packaging solutions for a wide range of drug-device combination product/drug delivery devices including auto-injectors, injection pens, reconstitution and dissolution devices, patch/pumps, pre-filled syringes, nasal spray devices, inhalers or other novel delivery technologies is highly preferredKnowledge of ISO 11607 is essentialKnowledge of FDA 21 CFR part 820, ISO 13485 Design Control and ISO 14971 Risk Management for Medical Devices is essential.Knowledge of ISO 11135 is desiredProficiency with 3D computer-aided design (SolidWorks preferred)Experience in a range of packaging/labelling processes e.g., tray thermoforming, operation of sealing equipment, etc. Experience with Design of Experiments (DOE) and statistical analysisTrack record of successfully managing third-party packaging/engineering design sub-contractors is essentialExcellent written communication skills and the ability to rapidly and robustly document DHF deliverables. Strong communication skills and ability to drive cross-functional decision makingThorough knowledge of industry standards, FDA guidance, quality systems, verification, validation, design transfer, and quality engineering principles for medical devices and combination productsDemonstrated ability to create and execute to technical plans and timelines (MS Project preferred)Experience mentoring other engineersExperience Level:Intermediate Level**This position has the opportunity to be 100% remote and open to any candidate nationwide** About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Rockville , Packaging Design Engineer (100% Remote), Other , Rockville, Maryland