Janssen Research & Development, LLC, a member of the Johnson and Johnson Family of Companies, is currently recruiting for a Senior Associate Packaging Engineer for their Springhouse Pa. location.
The Senior Associate 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 with minimum supervision of the senior staff. S/he assists in the development of standardized test procedures, policies, and standards for the department.
The Senior Associate 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 assists in development and maintenance of the 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, and 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.
This position could require up to 15% travel both domestic and international. Qualifications
- B.S. Degree in Packaging, Mechanical, Chemical or Materials Engineering with minimum 3 of experience.
- 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 cold chain shipping requirements involving CRT, 2-8C, frozen and cryo products preferred.
- Experience in packaging material specifications and qualification activities including laboratory testing is required.
- A team attitude with positive outlook is a must as is the ability to work with cross functional teams from R&D to commercial organizations.
- Ability to manage multiple projects is required.
- The ability to proactively assess/identify new opportunities to enhance the impact of package development on cross-functional projects and teams is preferred.
- Ability to assess technical opportunities as needed and to make appropriate recommendations to management is required.
- It is required to have experience in Design for manufacturability and scalability so seamless technical transfer to eventual commercial sites occurs.
- Demonstrated project budgeting and resource planning is required.
- Good communication skills, both written and oral, and ability to prepare technical reports and presentations is required.
- May require both domestic and international travel up to 15%.
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function