Validation Scientist - Medical Device Sterilization

Johnson & Johnson Co.; Warszawa; On-site; PLN 430,000 - 626,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Scientist, MQSA, located in Warsaw, IN, to lead validation efforts across microbiology and chemistry laboratories supporting medical device development and manufacturing.

You will author protocols, execute studies, analyze data, and ensure regulatory compliance with GLP and quality systems. This role requires collaboration with multiple internal teams and strong technical leadership.

Qualifications

• Bachelor's degree or higher in a related scientific discipline is required. Advanced degree preferred.
• Minimum 5–8 years in a regulated medical device/pharma/lab setting with validation experience.
• Experience authoring validation protocols and reports and leading IQ/OQ/PQ activities.

Responsibilities

• Author, execute, and review validation protocols, reports, risk assessments, and technical documentation.
• Develop validation strategies and acceptance criteria for device processing and sterilization.
• Lead validation projects from planning through final report approval and support CAPAs and deviations.
• Ensure compliance with quality systems, regulatory requirements, and industry standards.
• Collaborate with R&D, Quality, Regulatory Affairs, and manufacturing to support programs.

Skills

Validation protocols

IQ/OQ/PQ leadership

Temperature mapping

Sterilization validation

Education

Bachelor's degree in Microbiology/ Biology/ Chemistry/ Biomedical Eng

Advanced degree preferred

Tools

Laboratory instrumentation qualification

GLP/data integrity

Job description

Johnson & Johnson is seeking a Staff Scientist, MQSA, located in Warsaw, IN, to lead validation efforts across microbiology and chemistry laboratories supporting medical device development and manufacturing.

You will author protocols, execute studies, analyze data, and ensure regulatory compliance with GLP and quality systems. This role requires collaboration with multiple internal teams and strong technical leadership.