Sr. Scientist- MQSA (Supplier/EM)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

You will be responsible for:

• Supporting end‑to‑end Microbiological Quality & Sterility Assurance (MQ&SA) activities related to suppliers and external manufacturing processes
• Contributing to change requests and projects impacting controlled environments, cleaning, and sterilization processes
• Supporting contamination control strategies, including environmental monitoring and investigation activities
• Providing technical guidance and training on microbiological quality and sterility assurance
• Acting as subject matter expert for investigations, CAPA, non‑conformances, audit observations, and risk assessments
• Supporting due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA expertise and risk input
• Supporting development and updates of supplier quality agreements
• Coordinating and participating in supplier audits, including preparation, on‑site support, response review, and follow‑up activities
• Partnering with cross‑functional teams to support supplier qualification and lifecycle management
• Contributing to remediation activities following audits or regulatory findings
• Building strong relationships with external partners, including manufacturers, suppliers, sterilization providers, and testing laboratories

Qualifications / Requirements

• A minimum of a Bachelor’s Degree in Microbiology, Biological Sciences or Engineering is required
• Minimum 4 years of experience with microbiological and sterilization in the medical device and/or pharmaceutical industry is preferred
• Strong knowledge of microbiological control, contamination control, and sterilization processes
• Familiarity with applicable standards and regulations (e.g., ISO, EN, AAMI)
• Experience conducting or supporting investigations, test method development, and validation
• Knowledge of regulatory and quality requirements related to suppliers and external manufacturing
• Experience supporting audits, inspections, or compliance assessments
• Strong communication and collaboration skills, with the ability to work across functions and levels
• Ability to work independently while contributing effectively to team objectives
• Fluent in English (Spanish is a plus)
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

Required Skills:

 

 

Preferred Skills:

Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

 

 

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

Additional Description for Pay Transparency:

This position is eligible to participate in the Company’s long-term incentive program.



Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per ca