Senior Scientist, Microbiological Quality and Sterility Assurance

Johnson & Johnson

Senior Scientist responsible for sterility assurance practices in new and commercial products at Johnson & Johnson. Working in a hybrid setting across multiple US locations, enhancing product safety and compliance.

Posted 4/23/2026full-timeFlorida, Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $92,000 - $148,350 per yearWebsite

Tech Stack

Tools & technologies

Electron

About the role

Key responsibilities & impact

Support the end-to-end contamination control and sterility assurance practices for the development of new products and/or sustainment of commercial products.
Provide input for the following for increasing complexity projects: Design for cleanability, Design for decontamination, Design for sterilizability.
Drive selection of sterilization modality, validation approaches and validation of the sterilization process.
Generate sterilization product adoptions.
Support the regulatory approval of sterile and non-sterile new products, including internal research & development products, new acquisitions, and strategic partnerships.
Support the implementation of new innovations in the areas of contamination control, terminal sterilization, and reprocessing.
Provide sterility assurance and contamination control support for procurement activities that relate to sterile, non-sterile or microbiologically controlled products.
Lead non-conformance/CAPA pertaining to product cleanliness and sterility assurance.
Provide support to internal and external audits.

Requirements

What you’ll need

A minimum of 4 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment.
Demonstrated competency in terminal sterilization, Reprocessing, and microbiological contamination.
Demonstrated competency in multiple healthcare and industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
In a supervisory, coaching, mentoring and/or influencing capacity.
Proven track record on monitoring and troubleshooting process non-conformances and out of specification test results and providing resolution to issues by a robust CAPA process across multiple regions.
Proven track record on trouble shooting microbiological, aseptic processing and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via a robust CAPA process.
Strong knowledge of standards including EU, USA and ISO.
Excellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area.
Demonstrated ability to work in a collaborative/teamwork environment is required.
Independent organizational and time management skills.
Team player with a customer focus.
Competent in using computer software such as Excel, Word and PowerPoint, and analytical software.

Benefits

Comp & perks

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

terminal sterilizationreprocessingmicrobiological contaminationsterilization methodsEO sterilizationgamma sterilizationelectron beam sterilizationmoist heat sterilizationdry heat sterilizationCAPA process

Soft Skills

supervisory skillscoachingmentoringinfluencingproblem-solvingcollaborationorganizational skillstime managementcustomer focuscommunication skills