Posted: Friday, February 9, 2018 7:43 PM
Janssen Research & Development, LLC, a Johnson & Johnson Company, is hiring an Associate Packaging Engineer, to be located in Spring House, PA.
The 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 some supervision of the senior stuff. S/he assists in the development of standardized test procedures, policies, and standards for the department.
The Associate Packaging Engineer is a technical team representative 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 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. Up to 25% travel required.
- B.S. Degree in Packaging, Mechanical, Chemical or Materials Engineering with minimum 0-2 years of experience is required.
- Knowledge in the design, development, testing and commercialization of primary container systems for pharmaceutical products involving solid, liquid and parenteral dosage forms is required.
- Knowledge of GMP, ISO, FDA, NSTA, ISTA, ASTM, USP, EP, CFR and other regulatory issues relating to Pharmaceutical packaging systems is required.
- Some experience in cold chain shipping requirements involving CRT, 2-8C, frozen and cryo products is preferred.
- Experience in packaging material specifications and qualification activities including laboratory testing is preferred.
- 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 assess technical opportunities as needed and to make appropriate assessments and recommendations to management is required, as is, design for manufacturability and scalability so technical transfer to eventual commercial sites is seamless.
- The successful candidate will have good communication skills, both written and oral and ability to prepare technical reports and presentations.
- Creation of schedules and tracking of tasks to these schedules required, as is, proficiency in MS Office and project management programs.
- This position is located in Spring House, PA and may require both domestic and international travel up to 25% of the time.
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=0431180122&lang=en
• Location: Philadelphia
• Post ID: 62339887 philadelphia