Senior Validation Scientist, Sterility & Device Processing

NCSL International; Warsaw, Northern (IN, KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Johnson & Johnson in Warsaw, IN, seeks a Staff Scientist to lead validation programs within the Microbiology & Chemistry Laboratory. The role focuses on reusable device processing validations, sterilization studies, and analytical evaluations supporting product development and regulatory compliance.

Responsibilities include developing validation strategies, authoring protocols and reports, executing studies, analyzing data, and ensuring GLP and regulatory standards are met across IQ/OQ/PQ

Qualifications

• Bachelor’s degree in a life sciences field with relevant experience.
• Experience authoring validation protocols and reports.
• Hands-on IQ/OQ/PQ activities and validation lifecycle knowledge.
• Familiarity with GLP and data integrity requirements.

Responsibilities

• Author, execute, and review validation protocols, reports, and risk assessments.
• Lead validation projects from planning through final report approval.
• Support investigations, deviations, CAPAs, and audits.
• Ensure compliance with quality systems and regulatory standards.
• Perform temperature mapping and equipment qualification activities.

Skills

IQ/OQ/PQ

Validation lifecycle

Risk assessments

Technical report writing

Data integrity

GLP

Communication skills

Cross-functional collaboration

Education

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

Advanced degree preferred

Tools

Laboratory instrumentation

ASQ CQE/CQA

Job description

Johnson & Johnson in Warsaw, IN, seeks a Staff Scientist to lead validation programs within the Microbiology & Chemistry Laboratory. The role focuses on reusable device processing validations, sterilization studies, and analytical evaluations supporting product development and regulatory compliance.

Responsibilities include developing validation strategies, authoring protocols and reports, executing studies, analyzing data, and ensuring GLP and regulatory standards are met across IQ/OQ/PQ