Janssen Research & Development, LLC, a member of the Johnson and Johnson Family of Companies, is currently recruiting for a Packaging Engineer for their Springhouse Pa. location.
The Packaging Engineer within the Primary Container organization is responsible for the design, coordination, development and implementation of packaging systems for the pharmaceutical and biological businesses. Main support role is for experimental or new products but the incumbent will also support changes to primary container systems for existing or commercial products as required. This individual applies sound scientific, engineering and current regulatory knowledge for the planning and execution of development projects on a global scale. Executes and supervises scientific studies and manages laboratory activities. S/he manages the development of standardized test procedures, policies, and standards for the department.
The Packaging Engineer must function as a technical team leader for the Primary Container group within the Pharmaceutical Development and Manufacturing Sciences (PDMS) organization. This individual represents the department in project team meetings and works closely with other Pharmaceutical Development groups, Regulatory Affairs, Project Management, Manufacturing & Supply Chain, Quality, and Marketing to meet project timelines and objectives. S/he develops and maintains a current in-depth knowledge of global regulatory submission requirements, GLP/GMP requirements (ISO 9000 where required), and maintains up to date knowledge of state- of-the-art solutions and packaging strategies though trade journals, seminars, and trade shows.
Key responsibilities include developing container closure systems, primary packaging components, and cold chain transportation systems for a variety of dosage forms and delivery systems. Identify, design and evaluate new primary packaging concepts for eventual production use. Develop and execute package testing plans and interprets results as required for various projects; coordinate and perform activities associated with manufacturing line testing.
Develop packaging specifications and procedures for bulk, API, WIP, FG products including appropriate Container Closure Integrity methods and procedures. Provide guidance to the Clinical organization regarding primary packaging and dosing options regarding clinical studies. Support green packaging initiatives. Maintain ownership of primary container specifications and author pertinent sections of Regulatory Filings.
May require both domestic and international travel up to 15%.
Janssen Research & Development, LLC. (6084)