Principal Scientist, Microbiological Quality & Sterility Assurance

Johnson Johnson; Limerick; On-site; EUR 105,000 - 135,000; Full time

Job summary

Johnson & Johnson Vision seeks a Principal Scientist, Microbiological Quality & Sterility Assurance (MQSA) to lead end-to-end microbiological quality and sterility assurance strategies globally. The role covers NPI, method validation, regulatory support, aseptic processing, sterilization, and related areas with broad impact across all Vision locations.

The candidate will deploy company policies on cleanliness, aseptic processing, and packaging validation while steering quality initiatives and

Qualifications

• Experience leading microbiological quality and sterility programs.
• Strong knowledge of aseptic processing and sterilization.
• Regulatory affairs exposure and cross-functional collaboration.

Responsibilities

• Lead microbiological quality and sterility assurance strategies across Vision locations.
• Drive NPI support, validation workflows, and transfer of methods.
• Provide regulatory affairs support for submissions and inquiries.
• Oversee aseptic processing, clean rooms, and sterilization cycle development.
• Mentor and guide teams on contamination control and quality systems.

Skills

Microbiological quality

Aseptic processing

Sterilization

Regulatory affairs

NPI

Process validation

Job description

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 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 universities, internal and external experts, participating in development of new products.
• Work directly with the Technical Vertical MQSA Leaders to find break-even 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 NPI, review and approval of protocols and reports as SMEs.
• Life cycle management of aseptic processing, microbiological and/or sterilization process for product portfolio within Johnson & Johnson Vision.
• Support and drive the Technology Strategy for Johnson & Johnson Vision.
• Partner with R&D and drive sterility assurance strategy for new product development to include the BCP and environmental footprint for sterilization and contamination control.
• Where applicable, own and drive test method development, validations and transfer including review and approval of protocols and reports as SMEs.

Plan:

Support for the selection of new manufacturing operations (to include aseptic processing manufacturing sites, contamination control strategy, review of site competencies, contract sterilization, contract laboratories, external manufactures, critical suppliers and third-party manufacturers).

Review and SME input of quality agreements for sterilisation contracts, EMs, and (some part missing)

Site visits as required and requested, audit etc.

Source:

Mandatory involvement in due diligence for sterile or microbiologically controlled manufactured products, and provide technical SME support for integration into J&J.

Provide technical SME support for procurement activities that relate to sterile or microbiologically controlled products tha