Principal Scientist, Microbiological Quality & Sterility Assurance

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
R&D/Scientific Quality

Job Category:
Professional

All Job Posting Locations:
Limerick, Ireland

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

Principal Scientist, Microbiological Quality & Sterility Assurance (MQSA) Johnson & Johnson - Vision

The Principal Scientist, Microbiological Quality & Sterility Assurance (MQSA) position is responsible for the E2E execution of microbiological quality, sterility assurance policies and strategies for Johnson & Johnson Vision franchise which are aligned with the overall Johnson & Johnson microbiological sterility assurance strategic priorities.

He/she will serve as the global technical leader in the areas of New Product Introduction, Method/Product Validations/Transfers, Regulatory Affairs Support, aseptic processing, sterilization, and microbiological quality with responsibility for all Johnson & Johnson Vision locations worldwide.

This individual will be responsible for deployment of the company policy and company strategies with respect to cleanliness, aseptic processing, sterilization, clean rooms, water systems and microbiological quality related areas.

This individual will be responsible for activities such as, but not limited to, the following:

R&D:


* Core team member as required for NPI, selection of modalities, business case development, screening/feasibility cycle support, , protocol and report writing, liaise with Regulatory Affairs on potential requirements for submission.



* Drive new contract sterilisation site validation - on site visits, cycle development, process characterization, process validations, protocol and reports, regulatory affairs support for submissions, and questions from regulatory bodies.



* Support the development of new innovations in the area of contamination control and terminal sterilization, to include such activities as interaction with universit...