Job Title: Packaging Design Engineer
This section focuses on the main purpose of the job in one to four sentences.
This position reports to Principal Packaging Design Engineer and is responsible for designing and developing packaging solutions, creating and updating packaging technical specifications and support the implementation of new labeling process.
The incumbent partners and interacts with internal cross functional teams and team members as well as with external suppliers, vendors and service providers.
(Primary products supported and packaged are glass vials containers, Vial labels, leaflet, secondary and tertiary packaging components/materials and a variety of sterile and sterile fluid path disposable sets and devices).
Essential Duties and Responsibilities: This section contains a list of five to eight primary responsibilities of this role that account for 80% or more of the work. The incumbent will perform other duties assigned.
• The incumbent works closely with Labelling Development, Material Change Management, and Packing Operations groups, to ensure adequate solutions are developed and implemented for US products, according to regulatory, operations, and customer requirements.
• Work with close collaboration with the appropriate departments to ensure that the new labeling change request process is implemented.
• Develop and maintain packaging technical specifications to ensure their compliance with changes.
• Support protocol development, test execution and final report as well as engaging in change control activities interfacing with multiple functional groups internally including multiple manufacturing plants as well as externally with suppliers.
• Willingness to invest time and energy in understanding the company's business and manufacturing/packaging processes.
• Assure timely and effective project completion of assigned tasks under labeling process.
• Develop database for the technical specifications, product configuration and master validation plan.
• Support labeling change request process (LCR) by evaluating the impact on packaging material and on the packing operations, participating in creation of Bill of Material and supporting local Engineering for implementation.
• Serve as technical expert for all aspects of packaging design development and support the implementation.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The incumbent must demonstrate:
• An in-depth understanding of all aspects of packaging component design and development.
• Excellent communication skills, both written and oral, (with staff, colleagues, suppliers, and senior management).
• Ability and initiative to seek, listen, and leverage the partnering with internal and external cross –functional teams and team members to do/get it right the first time.
• Embraces change, challenges status quo and makes recommendations for improvements to products and processes. Creates tools that help simplify job tasks and shares or implements these with others
• Strong interpersonal skills and be able to work effectively and efficiently in a team environment.
• Experience with Change Management in a GMP environment
• Proficiency in negotiations and technical problem solving is required to interact with various departments, divisions, and vendors to resolve issues and achieve goals.
• Experience on creative Suite tools use (Illustrator, InDesign…)
• Ensuring compliance with internal and external international standards for packaging design and validation, including but not limited to the requirements provided in ISO 11607-1; BS EN 868-5; ASTM D4169-16, ASTM F1140; ASTM F1929; ISTA 2A.
Education and/or Experience: Include the education and experience that is necessary to perform the job satisfactorily.
• Bachelor’s degree in packaging with 6-7 years of related experience or 10 years related experience in a regulated packaging operations environment.
• Packaging Engineering degree or experience.
• Experience in working in Biopharmaceutical or highly regulated and compliance industry
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