Senior Engineer, Primary Container
Johnson and Johnson is recruiting for a Senior Engineer, Primary Container located in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
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.