Lead Validation Scientist, Medical Devices & Sterilization

Johnson Johnson; Warsaw (IN); On-site; USD 110,000 - 140,000; Full time

Job summary

Johnson & Johnson is recruiting a Staff Scientist, MQSA to join the Microbiology & Chemistry Laboratory in Warsaw, IN. The role focuses on validation strategies for reusable medical devices, manufacturing residuals, sterilization studies, and regulatory compliance.

The position requires developing protocols, leading validation projects, and collaborating with R&D, Quality, Regulatory Affairs, and Manufacturing to support product development and quality operations.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Chemistry, Biomedical or Chemical Engineering. Advanced degree preferred.
• Minimum 5–8 years in a regulated medical device or pharma lab environment.
• Experience authoring validation protocols and reports; leading IQ/OQ/PQ activities.

Responsibilities

• Lead validation projects from planning through final report approval.
• Author, execute, and review validation protocols and reports; assess risk and ensure documentation.
• Perform cleaning, sterilization, and device processing validations; conduct temperature mapping.
• Support regulatory submissions with technical justifications and data analyses.

Skills

Validation mastery

IQ/OQ/PQ leadership

Regulatory compliance

Temperature mapping

Sterilization validation

Education

Bachelor’s degree in Microbiology/Biology/Chemistry/Biomedical or Chemical Engineering

Advanced degree preferred

Tools

TOC analysis

Conductivity testing

Temperature mapping equipment

Sterilizers/autoclaves

Job description

Johnson & Johnson is recruiting a Staff Scientist, MQSA to join the Microbiology & Chemistry Laboratory in Warsaw, IN. The role focuses on validation strategies for reusable medical devices, manufacturing residuals, sterilization studies, and regulatory compliance.

The position requires developing protocols, leading validation projects, and collaborating with R&D, Quality, Regulatory Affairs, and Manufacturing to support product development and quality operations.