Senior Validation Scientist – Medical Devices

Johnson & Johnson Innovative Medicine; Warsaw (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Scientist, MQSA in Warsaw, IN to lead validation programs for reusable medical device processing, sterilization studies, and regulatory compliance. You will draft protocols, analyze data, and ensure quality systems across R&D, Manufacturing, and Quality groups.

The role focuses on validation strategy, study execution, and technical reporting, with collaboration across multiple departments to support product development and manufacturing operations.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or related scientific discipline.
• Advanced degree preferred.
• Minimum 5-8 years in a regulated medical device, pharmaceutical, biotechnology, or laboratory environment.
• Experience authoring validation protocols and reports; hands-on IQ/OQ/PQ activity.

Responsibilities

• Lead validation projects from planning through final report approval.
• Develop validation strategies and acceptance criteria for device processing and sterilization validations.
• Design and conduct manufacturing residual and analytical evaluations.
• Lead equipment qualification and lifecycle management (IQ/OQ/PQ).
• Perform temperature mapping and thermal validation studies.

Skills

Technical leadership

Validation

Data analysis

Regulatory compliance

Written communication

Education

Bachelor’s degree in Microbiology, Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or related scientific discipline

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Staff Scientist, MQSA in Warsaw, IN to lead validation programs for reusable medical device processing, sterilization studies, and regulatory compliance. You will draft protocols, analyze data, and ensure quality systems across R&D, Manufacturing, and Quality groups.

The role focuses on validation strategy, study execution, and technical reporting, with collaboration across multiple departments to support product development and manufacturing operations.