Staff Scientist, MQSA
About The Position
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.
Requirements
- Bachelor's degree in Microbiology, Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or related scientific discipline.
- Minimum 5-8 years of experience in a regulated medical device, pharmaceutical, biotechnology, or laboratory environment.
- Demonstrated experience authoring validation protocols and reports.
- Hands-on experience leading equipment IQ/OQ/PQ activities.
- Experience performing temperature mapping and thermal validation studies.
- Experience supporting sterilization, cleaning, or reusable device processing validations.
- Demonstrated expertise in Validation & Quality Systems, IQ/OQ/PQ methodology, Validation lifecycle management, Risk assessments, Technical report writing, Good Laboratory Practices (GLP), Data integrity requirements.
- Knowledge of Regulatory & Industry Standards: AAMI ST98, ISO 17665, ISO 11737, ISO 11137, ISO 15883, ISO 13485.
- Technical knowledge in Steam sterilization validation, Reusable medical device processing, Cleaning and disinfection validation, Manufacturing residual assessments, Temperature mapping, Thermal validation, Laboratory instrumentation qualification, Environmental monitoring systems.
Nice To Haves
- Advanced degree preferred.
- Experience in medical device product development.
- Experience supporting FDA, notified body, or regulatory inspections.
- ASQ certification (CQE, CQA, or equivalent).
- Experience establishing or expanding laboratory validation programs.
- Strong statistical, technical writing, and project management skills.
Responsibilities
- 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.
- 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, and technical reporting.
- Design and conduct manufacturing residual assessments.
- Support cleaning agent and process chemical residual evaluations.
- Lead extraction and recovery studies.
- Support TOC, conductivity, and analytical method validation activities.
- Evaluate data trends and prepare technical justifications for regulatory submissions and product development programs.
- Lead qualification and requalification activities for: Refrigerators, Freezers, Incubators, Laboratory ovens, Steam sterilizers/autoclaves, Washer-disinfectors, Glass washers, Water purification systems, Environmental monitoring systems, Temperature monitoring systems. Activities include: User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Calibration assessments, Requalification protocols and reports.
- Design and execute temperature mapping studies.
- Conduct thermal validation of sterilizers, incubators, refrigerators, freezers, and controlled storage environments.
- Analyze temperature distribution and heat penetration data.
- Generate validation reports and recommendations.
- Support regulatory inspections and audits related to thermal validation programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
