Staff Scientist, MQSA Full-time NEW

Staff Scientist, MQSA

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

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
• Device Processing & Sterilization Validations
• Manufacturing Residual & Analytical Evaluations
• Equipment Qualification & Lifecycle Management
• Temperature Mapping & Thermal Validation

Required Qualifications

• Education
• Experience
• Technical Knowledge

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

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.