Staff Scientist, MQSA

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

R&D/Scientific Quality

Job Category

Professional

All Job Posting Locations

Warsaw, Indiana, United States of America

Job Description

Johnson & Johnson is currently recruiting for a Staff Scientist, MQSA! This position will be located in Warsaw, IN.

The Staff Scientist will serve as a technical leader within the Microbiology & Chemistry Laboratory, supporting medical device development, manufacturing, and quality operations through the execution of validation and qualification programs. This role is responsible for developing validation strategies, authoring protocols and reports, executing studies, analyzing data, and ensuring compliance with global regulatory requirements and industry standards.

The position focuses on reusable medical device processing validations, manufacturing residual evaluations, sterilization studies, laboratory equipment qualifications, temperature mapping, and regulatory compliance activities. The Staff Scientist will work closely with R&D, Quality, Regulatory Affairs, Manufacturing, and other internal laboratory scientists to support product development and laboratory operations.

Key Responsibilities

• Validation Project Leadership
  • Author, execute, and review validation protocols, reports, risk assessments, and technical documentation.
  • Develop scientifically sound validation strategies and acceptance criteria.
  • Lead validation projects from planning through final report approval.
  • Support investigations, deviations, change controls, CAPAs, and audit activities.
  • Ensure compliance with internal quality systems, regulatory requirements, and industry standards.
• Device Processing & Sterilization Validations
  • Lead and support validation activities involving:
  • Reusable medical device processing validations
  • Cleaning and disinfection validations
  • Steam sterilization validations
  • Simulated-use studies
  • Soil recovery and extraction studies
  • Method suitability evaluations
  • Sterility assurance assessments
  • Responsibilities include protocol development, study execution, data analysis, and technical reporting.
• Manufacturing Residual & Analytical Evaluations
  • Design and conduct manufacturing residual assessments.
  • Support cleaning agent and process chemical residual evaluations.
  • Lead extraction and recovery studies.
  • Support TOC, conductivity, and analytical method validation activities.
  • Evaluate data trends and prepare technical justifications for regulatory submissions and product development programs.
• Equipment Qualification & Lifecycle Management
  • Lead qualification and requalification activities for:
  • Refrigerators
  • Freezers
  • Incubators
  • Laboratory ovens
  • Steam sterilizers/autoclaves
  • Washer-disinfectors
  • Glass washers
  • Water purification systems
  • Environmental monitoring systems
  • Temperature monitoring systems
  • Activities include:
  • User Requirement Specifications (URS)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Calibration assessments
  • Requalification protocols and reports
• Temperature Mapping & Thermal Validation
  • Design and execute temperature mapping studies.
  • Conduct thermal validation of sterilizers, incubators, refrigerators, freezers, and controlled storage environments.
  • Analyze temperature distribution and heat penetration data.
  • Generate validation reports and recommendations.
  • Support regulatory inspections and audits related to thermal validation programs.

Required Qualifications

Education

• Bachelor's degree in Microbiology, Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or related scientific discipline.
• Advanced degree preferred.

Experience

• Minimum 5-8 years of experience in a regulated medical device, pharmaceutical, biotechnology, or laboratory environment.
• Demonstrated experience authoring validation protocols and reports.
• Hands-on experience leading equipment IQ/OQ/PQ activities.
• Experience performing temperature mapping and thermal validation studies.
• Experience supporting sterilization, cleaning, or reusable device processing validations.

Technical Knowledge

• The successful candidate must have demonstrated expertise in:
• Validation & Quality Systems
• IQ/OQ/PQ methodolo