Sr. Scientist- MQSA (Supplier/EM) Full-time

Microbiological Quality & Sterility Assurance Specialist

You will be responsible for:

1. Supporting end-to-end Microbiological Quality & Sterility Assurance (MQ&SA) activities related to suppliers and external manufacturing processes
2. Contributing to change requests and projects impacting controlled environments, cleaning, and sterilization processes
3. Supporting contamination control strategies, including environmental monitoring and investigation activities
4. Providing technical guidance and training on microbiological quality and sterility assurance
5. Acting as subject matter expert for investigations, CAPA, non-conformances, audit observations, and risk assessments
6. Supporting due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA expertise and risk input
7. Supporting development and updates of supplier quality agreements
8. Coordinating and participating in supplier audits, including preparation, on-site support, response review, and follow-up activities
9. Partnering with cross-functional teams to support supplier qualification and lifecycle management
10. Contributing to remediation activities following audits or regulatory findings
11. 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 calendar year Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time – up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period 10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits