Description
Johnson and Johnson is recruiting for a Senior Engineer, Primary Container located in Spring House, PA.
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The Senior Engineer within the Primary Container organization is responsible for the design, coordination, development and implementation of packaging systems for the pharmaceutical and biological businesses. This role will primarily provide support for experimental or new products, but will also support changes to primary container systems for existing or commercial products as needed. This individual will apply sound scientific, engineering and current regulatory knowledge for the planning and execution of development projects on a global scale. They will complete and supervise scientific studies and manage laboratory activities with minimum supervision of the senior staff. Assist in the development of standardized test procedures, policies, and standards for the department.
The Senior 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. They will assist in development and maintenance of the current in-depth knowledge of global regulatory submission requirements, GLP/GMP requirements (ISO 9000 where required), and maintain up to date knowledge of state- of-the-art solutions and packaging strategies though trade journals, seminars, and trade shows.
Key Responsibilities:

• Develop 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 complete package testing plans and interpret results as needed for various projects; coordinate and perform activities associated with manufacturing line testing.
• Create 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.

Qualifications
Education:

• Bachelor's degree in Packaging, Mechanical, Chemical or Materials Engineering with a minimum of 3 years of relevant experience.

Experience and Skills:

• 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 preferred.
• 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 is preferred.
• Experience in packaging material specifications and qualification activities including laboratory testing is preferred.
• Team attitude, positive outlook with the ability to work with cross-functional teams from R&D to commercial organizations is required.
• Ability to manage multiple projects is required.
• Ability to proactively assess/identify new opportunities to improve the impact of package development on cross-functional projects and teams is preferred.
• Ability to assess technical opportunities and make appropriate recommendations to management is required.
• Experience in design for manufacturability and scalability for seamless technical transfers to eventual commercial sites is preferred.
• Demonstrated project budgeting and resource planning is preferred.
• Excellent verbal and written communication skills, with the ability to prepare technical reports and presentations is required.

Other:

• May require up to 10% domestic and international travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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