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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, and technical

reporting.

Manufacturing Residual & Analytical Evaluations

• 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.

Equipment Qualification & Lifecycle Management

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

Temperature Mapping & Thermal Validation

• 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.

Required Qualifications

Education

• Bachelor's degree in Microbiology, Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or related scientific discipline.
• Advanced degree preferred.

Experience

• 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.

Technical Knowledge

The successful candidate must have 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

Regulatory & Industry Standards

• AAMI ST98
• ISO 17665
• ISO 11737
• ISO 11137
• ISO 15883
• ISO 13485

Technical Areas

• Steam sterilization validation
• Reusable medical device processing
• Cleaning and disinfection validation
• Manufacturing residual assessments
• Temperature mapping
• Thermal validation
• Laboratory instrumentation qualification
• Environmental monitoring systems

Preferred Qualifications

• 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.

Key Competencies

• Technical leadership
• Scientific problem solving
• Validation expertise
• Regulatory compliance awareness
• Strong written and verbal communication skills
• Cross-functional collaboration
• Attention to detail
• Ability to manage multiple complex projects simultaneously

This position serves as a primary technical resource for validation activities within the Microbiology & Chemistry Laboratory, ensuring equipment, processes, and test methods are developed, qualified, and maintained in compliance with applicable regulatory and quality requirements.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
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