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Raritan, NJ, US

Process & Technology Transfer Principal Engineer-4905121206

Description

Janssen Research and Development, LLC, a member of the Johnson and Johnson Family of Companies, is recruiting for a Process & Technology Transfer Principal Engineer to be located at Raritan, NJ and Titusville, NJ.

Janssen research and Development, LLC develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.

The Process & Technology Transfer Principal Engineer is responsible for the engineering aspects of technology transfers of Drug Product processes from PDMS (R&D) to Janssen Supply Chain (JSC) sites or to external partners: He/ She will start from the detailed knowledge of the processes during development and as they run at the clinical Pilot Plant site (internal or external). The individual will deliver PDMS design inputs for the receiving commercial site (URS and process requirements) and then follow up on the progress of the project together with the rest of the Technology Transfer team to assure timely readiness of the installation and equipment at the receiving site.

The Process & Technology Transfer Principal Engineer's activities include, but are not limited to the following: the concept, design, installation and implementation of new equipment; optimizations and / or changes to existing equipment; technology transfer support: commercial plant readiness for registration, launch and commercial production, including Design of Experiments & scale-up and the follow up of clinical batches at external partners.

Qualifications


A minimum of a Bachelors degree is required. A degree in mechanical or chemical engineering or closely related discipline and/ or an advance degree are preferences. A minimum of 10 years related work experience in the pharmaceutical industry is required. Experience with pharmaceutical engineering with a particular emphasis on oral solids dosage is required. An in depth knowledge of orals dosage products, processes and technologies is required. Experience with conventional technologies (such as capsulation, tableting, granulation, coating etc) is required. Working knowledge and/ or experience with innovative technologies (such as spray drying, extrusion, nanomiling, nasal delivery platforms, etc) and parenteral Fill/Finish activities would be highly desired. A broad technical background with reference to equipment, facilities and utilities (such as electrical, pneumatic, mechanics, HVAC, etc) is required. Basic knowledge of equipment qualification, validation and change management systems in the pharmaceutical industry is required.

A demonstrated ability to work in highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines) is required. The successful candidate must possess or be able to build an excellent internal and external network of engineering and development specialists. Excellent communication skills, both verbal and written, to effectively collaborate in a global and cross functional environment is a requirement, along with the ability demonstrate to work independently with minimal supervision. Any additional language skills will be a plus.

This position may require up to 25% domestic or international travel, as needed by business. It is a preference that this position will be based in Raritan, NJ; alternately this position may also be based in Titusville, NJ.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-New Jersey-Titusville
Organization: Janssen Research & Development, LLC. (6084)