Staff Scientist: Validation & Sterilization Expert

Brighter Signals; Warsaw (IN); On-site; USD 90,000 - 140,000; Full time

Job summary

Johnson & Johnson is recruiting a Staff Scientist, MQSA, to lead validation programs in the Microbiology & Chemistry Laboratory in Warsaw, IN. The role focuses on reusable device processing validations, sterilization studies, and regulatory compliance.

The ideal candidate will have 5–8 years in a regulated setting, experience authoring validation protocols, and strong data analysis skills. You will collaborate closely with R&D, Quality, Regulatory Affairs, and Manufacturing teams.

Qualifications

• Bachelor's degree in a life science or engineering field.
• Advanced degree preferred.
• 5–8 years of experience in a regulated medical device or biotech environment.
• Experience authoring validation protocols and reports.
• Hands-on IQ/OQ/PQ experience.
• Experience with temperature mapping and thermal validation.
• Experience supporting sterilization, cleaning, or reusable device validations.

Responsibilities

• Lead validation projects from planning through final report approval.
• Develop validation strategies and acceptance criteria.
• Prepare protocols, reports, and risk assessments.
• Support regulatory submissions and product development programs.
• Coordinate with R&D, Quality, Regulatory Affairs, and Manufacturing.

Skills

IQ/OQ/PQ methodology

Validation lifecycle

Data integrity

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in life sciences or engineering

Advanced degree preferred

Job description

Johnson & Johnson is recruiting a Staff Scientist, MQSA, to lead validation programs in the Microbiology & Chemistry Laboratory in Warsaw, IN. The role focuses on reusable device processing validations, sterilization studies, and regulatory compliance.

The ideal candidate will have 5–8 years in a regulated setting, experience authoring validation protocols, and strong data analysis skills. You will collaborate closely with R&D, Quality, Regulatory Affairs, and Manufacturing teams.