Packaging Engineer – Janssen Research & Development, LLC. – Spring House, PA, USA
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 and WIP 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.
- A B.S. Degree in Packaging, Mechanical, Chemical or Materials Engineering or related discipline with minimum 5 years of experience is required.
- Knowledge in the design, development, testing and commercialization of primary container systems for FDA and Global Regulated Agency products involving solid, liquid and parenteral dosage forms is required.
- Understanding of Design Controls and how they would apply to Combination products from a packaging perspective and ISO 13485 and 14971 for Risk management is preferred.
- Experience in packaging material specifications and qualification activities including laboratory testing is required.
- Ability to manage multiple, complex projects is required.
- Ability to assess technical opportunities as needed and to make appropriate assessments and recommendations to management is preferred.
- Design for manufacturability and scalability so technical transfer to eventual commercial sites is seamless is required.
- Demonstrated project management competencies in budgeting and resource planning and management required.
- This position is located in Spring House, PA and may require both domestic and international travel up to 15% of the time.