Description:
The Packing Engineer will lead and/or support packaging engineering activities for development, capacity expansion, continuity of supply and maintenance of business functions.
Responsibilities:
- Lead engineering activities in the design, development and qualification of primary and secondary packaging for medical device and pharmaceutical products
- Support and/or lead the engineering activities associated with the design and development of new innovative packaging systems for existing products and R&D pipeline products
- Participate in the identification, selection, specification and qualification of primary and secondary packaging components
- Lead/contribute to the critique of new/modified packaging designs for robustness as it relates to product protection, packaging process performance, and regulatory compliance
- Lead troubleshooting of packaging component and/or packaging process issues with established platforms
- Contribute to the identification of new packaging materials, technologies and equipment that will add convenience for customers, reduce manufacturing and material costs, and improve efficiencies
- Create and execute packaging test protocols and methods
- Develop and execute design of experiments to establish robust packaging process performance
- Develop/raise packaging material and component specifications/drawings
- Lead packaging component and process qualifications with generation of appropriate documentation
Qualifications:
- BS Packaging Science or related Engineering discipline
- 7+ years of Packaging Engineering experience in the pharmaceutical or medical device industry
- Experience with primary and secondary packaging materials including, but not limited to, bottles, closures, dropper tips, tubes, labels, cartons, inserts, and corrugated shippers
- Must possess strong communication and interactive skills, capable of working independently or on project teams as required
- Must be able to work with Engineering, Procurement, Manufacturing and external Suppliers in a team setting
- Experience with participating on technical projects from start to finish and working with external manufacturing suppliers
Preferred Skills:
- ISO-9000, GMP, medical device manufacturing experience
- Design for Experiments (DOE) experience a plus
- Project leadership and familiarity with FDA regulated products
- Experience and knowledge of aseptic automated packaging processes
- Ability to write technical reports and make presentations
- A self-starter able to achieve project goals with minimal supervision