Staff Scientist, Microbiological Quality & Sterility Assurance

Johnson Johnson; Groningen; On-site; EUR 85,000 - 120,000; Full time

Job summary

Johnson & Johnson Vision is seeking a Staff Scientist for Microbiological Quality & Sterility Assurance (MQSA) to lead end-to-end quality and sterility strategies. This role spans global locations and focuses on microbiological quality, aseptic processing, and regulatory support.

You will support New Product Introductions (NPI), method validations/transfers, and contamination control, partnering with R&D, QA, and manufacturing to ensure compliant, safe products.

Responsibilities

• Lead end-to-end microbiological quality and sterility assurance activities across global locations.
• Provide on-site validation for new contract sterilization sites, including cycle development and validations.
• Collaborate on contamination control and terminal sterilization solutions with academia and industry partners.
• Support assay method development, validations and transfer as SMEs, coordinating with Regulatory Affairs.
• Partner with R&D, QA, and manufacturing to ensure sterility and quality throughout product life cycle.

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

Groningen, Netherlands

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

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

The Staff Scientist, Microbiological Quality & Sterility Assurance (MQSA) at Johnson & Johnson Vision is responsible for the end-to-end execution of microbiological quality and sterility assurance strategies and policies. These responsibilities will align with the strategic priorities of Johnson & Johnson's microbiological sterility assurance initiatives.

In this role, the Staff Scientist will support the global technical leader in areas including New Product Introductions (NPI), Method/Product Validations/Transfers, Regulatory Affairs Support, aseptic processing, sterilization, and microbiological quality across all Johnson & Johnson Vision locations worldwide. This individual will oversee the implementation of company policies concerning cleanliness, aseptic processing, sterilization, clean rooms, water systems, and microbiological quality.

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

R&D

• o Serve as a core team member for NPI, collaborating on modality selection, business case formulation, and protocol/report writing while liaising with Regulatory Affairs for submission requirements.
• o Lead on-site validation for new contract sterilization sites, which includes conducting visits, cycle development, process characterization, validations, and providing regulatory support.
• o Collaborate on innovative contamination control and terminal sterilization solutions, engaging with academic and industry experts.
• o Work closely with Technical Vertical MQSA Leaders to explore groundbreaking technologies that support future growth.
• o Support defining packaging requirements for terminal sterilization/aseptic processing, participating in review and approval of relevant protocols and reports.
• o Partner with biocompatibility and chemistry teams to evaluate the impacts of sterilization on product requirements.
• o Life cycle management of aseptic processing, microbiological and/or sterilization process for product portfolio within 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 undefined.
• Where applicable, own and drive test method development, validations and transfer including review and approval of protocols and reports as SMEs.

Plan

• Provide 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 provide expert input into quality agreements for sterilisation contracts, EMs, contract labs etc.
• o Conduct site audits as needed to ensure compliance and support corrective actions post-audit.

Source

• o Participate in due diligence for sterile or microbiologically controlled products, offering technical expertise for integration into Johnson & Johnson.
• o Provide technical SME support for procurement activities that relate to sterile or microbiologically controlled products that are externally manufactured.
• o Assist in the design of new manufacturing processes, controlled environments, and cleanliness control strategies.
• Support change control and process improvements, cost avoidance projects, BCP, increased capacity.
• o Support updates and improvements for relevant procedures in sterilization, microbiology, and cleanroom management.
• Microbiological/chemical, new equipment and test method validations - input, protocol/report review and appr