Principal Scientist (Sterility Assurance)

Johnson & Johnson (Limerick, Ireland) 4 days ago

Position overview

Johnson & Johnson Vision – Microbiological Quality & Sterility Assurance (MQSA), is currently recruiting a Scientist who will be responsible for working on multiple initiatives in support of business/technical objectives in end to end (E2E) MQSA. The candidate will be a key contact to J&J-Vision as a MQSA Subject Matter Expert (SME) for the franchise.

In this role, he/she will serve as a project lead for the extended MQSA team supporting new product /process/packaging development & optimization, and validation of healthcare (Medical Devices and Pharmaceuticals) and consumer products. Providing exposure and visibility with the Franchise and Business Segment senior leaders. J&J is committed to the professional development of its employees and this is a great opportunity to show case your skills as a MQSA professional providing potential new opportunities within the J&J family of companies.

Tasks & Responsibilities:

  • R&D – Support our Design Teams in the development, validation, and introduction of new products along with innovative methods for manufacturing and testing.
  • Plan – Enables the scalability and sustainability of our processes through direct J&J site support as well as external manufacturing and contract sterilizers.
  • Source – Provide technical support in the identification of suppliers, external manufactures, and contract sterilizers to ensure sustainability and appropriate microbiological controls. Serve as a SME for the supplier quality team.
  • Make – Supports the manufacturing and operating companies/business units, while partners with QC for environmental monitoring, microbiological testing, investigations or corrective actions, and associated compliance requirements for manufactured commercial products. Moreover, will provide support during investigations impacting J&J End to End (E2E) model.
  • Deliver – Responsible for sterilization related questions from regulatory agencies (FDA, TUV and other associated regulatory/competent authorities), as well as, from internal and external audits.


Qualifications & Experience

  • Individual must have a minimum Bachelor’s in Microbiology, Biology, or closely related discipline or 8 years of direct experience.
  • A minimum of 8 years related experience is required.
  • Expertise and hands on experience in the areas of microbiology, biologics, ethylene oxide (EO), gamma radiation and other gaseous/heat sterilization modalities. Additionally, experience in cleanroom environments and critical utilities.
  • Strong knowledge in quality systems and compliance as it relates to the sterilization processes and new product introduction.
  • Demonstrated ability to develop and deliver instructional training material to the internal and external sterilization community is desired.
  • Excellent written and verbal communication skills, while demonstrating effective time & program management skills to allow for multi-tasking responsibilities.
  • Ability to work in a matrix environment, with senior level management, and ability to influence and present for multi-disciplinary teams.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function
Requisition ID

Principal Scientist (Sterility Assurance)

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