Staff Scientist, MQSA

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Job Function:
Quality

Job Sub Function:
R&D/Scientific Quality

Job Category:
Professional

All Job Posting Locations:
Warsaw, Indiana, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Staff Scientist, MQSA! This position will be located in Warsaw, IN.

Position Summary

The Staff Scientist will serve as a technical leader within the Microbiology & Chemistry Laboratory, supporting medical device development, manufacturing, and quality operations through the execution of validation and qualification programs.

This role is responsible for developing validation strategies, authoring protocols and reports, executing studies, analyzing data, and ensuring compliance with global regulatory requirements and industry standards.

The position focuses on reusable medical device processing validations, manufacturing residual evaluations, sterilization studies, laboratory equipment qualifications, temperature mapping, and regulatory compliance activities.

The Staff Scientist will work closely with R&D, Quality, Regulatory Affairs, Manufacturing, and other internal laboratory scientists to support product development and laboratory operations.

Key Responsibilities

Validation Project Leadership


* Author, execute, and review validation protocols, reports, risk assessments, and technical documentation.


* Develop scientifically sound validation strategies and acceptance criteria.


* Lead validation projects from planning through final report approval.


* Support investigations, deviations, change controls, CAPAs, and audit activities.


* Ensure compliance with internal quality systems, regulatory requirements, and industry standards.

Device Processing & Sterilization Validations

Lead and support validation activities involving:


* Reusable medical device processing validations


* Cleaning and disinfection validations


* Steam sterilization validations


* Simulated-use studies


* Soil recovery and extraction studies


* Method suitability evaluations


* Sterility assurance assessments

Responsibilities include protocol development, study execution, data analysis,...