MSIT Engineer.

Caring for the world … one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Innovative Medicine work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Main Responsibilities

In this multidisciplinary role, you will be a member of MSIT executing project activities in different areas of (new) biopharmaceutical processes in the Late Stage Development department. The MSIT Engineer is responsible for covering priority activities in validations, qualifications, cleaning or monitoring studies, zone concepts and other MSIT Drug Substance or Drug Product activities. This role gives you a broad area of insight and development of unique experience of GMP related MSIT work with new areas and challenges with each new task. You perform technical work under general supervision of experienced Subject Matter Experts, providing you with knowledge of the specific area and expanding your expertise therewith. If you look for a diverse role in different areas of expertise, are interested in learning about GMP processes from all angles, this is the job for you!

Essential duties:

? Collaborate in implementation projects for Drug Substance or Drug Product under GxP for the production of vaccines and other products

? Represent MSIT functions in project teams

? Deliver specific project tasks based on project milestones/priorities based on area of expertise

? Writing documents and supporting document readiness for activities in the production units

? Establish, review and Implementation of process related procedures

? Evaluate product/process performance and deviations, troubleshooting, performance of change activities, tracking and reporting key production and quality indicators against established metrics

? Propose new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance

? Collaborate with GMP Operations for investigations, change controls, data verification and process improvements

? Lead specific Qualification and Validation project activities related to manufacturing processes, equipment and cleanrooms