Principle Scientist MQSA

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

Job Function:
Quality

Job Sub Function:
R&D/Scientific Quality

Job Category:
Professional

All Job Posting Locations:
Groningen, Netherlands

Job Description:

Description

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 universities, internal and external experts, participating in development of new products


* work directly with the Technical Vertical MQSA Leaders to find break-through technologies to enable future growth and innovations


* work directly with the packaging leaders to define package needs for terminal sterilization and/or aseptic processing, and validation of the primary packaging, review and approval of protocols and reports as SMEs


* work directly with the biocompatibility and chemistry to support the impact of sterilisation on Biocomp and chemistry requirements for terminal sterilization and/or aseptic processing, and validation of the N...