Microbiology Quality & Sterility Assurance (MQSA), Scientist

The MQSA Scientist

The MQSA Scientist will serve as a technical leader in microbiological quality, sterilization, and reprocessing, partnering across product development and manufacturing teams to support safe, effective, and compliant medical devices. As a site subject matter expert, this individual will apply technical knowledge and scientific expertise to strengthen microbiological controls, advance sterilization strategies, and help ensure the highest standards of product quality.

This role offers the opportunity to contribute directly to patient safety while collaborating with a talented team of scientists and engineers.

• Works with Product Development Teams to ensure the microbiological quality requirements are established and met based upon the customer and regulatory needs.
• Develops radiation sterilization validations or product adoptions of new products.
• Develops/validates reusable medical device reprocessing instructions (i.e., cleaning, disinfection and/or sterilization) or adopts products into existing health care facility clinical processing instructions.
• Coordinates the requalification activities needed to ensure a compliant Ethylene Oxide (EO) sterilization program.
• Investigation of non-conformances, and implementation of corrective actions, and recommend disposition of product.
• Preparation and evaluation of trending data. Increases awareness of out of specification (OOS) results.
• Preparation and routing of documents for the change request/change order processes.
• Experience writing standard operating procedures, validation protocols, and validation reports.
• Compliance with GMP/GDP requirements and guidelines.

Education:

• Bachelors or equivalent university degree in Microbiology, Biomedical Science, Engineering, Sterility Assurance, Food Science or related field.

Required:

• Minimum of 2 years of sterilization/microbiological experience in the medical device, pharmaceutical and/or food science industries.
• Solid understanding of applicable FDA (QMSR) regulations.
• Experience in the field of microbiology or quality assurance, in the production of sterile products.
• MS Office skills.
• Strong teamwork and interpersonal skills.
• Analytical and critical thinking skills are essential with strict attention to detail.

• Experience writing standard operating procedures, validation protocols, and validation reports.
• Knowledge of EU, cGMP and cGLP regulations is strongly preferred.

• Up to 10% domestic travel may be required.
• Must be fluent in spoken and written English.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via  Internal employees contact AskGS to be directed to your accommodation resource.