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Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

Johnson & Johnson is recruiting for an MQSA Scientist II to join their team in Raynham, MA.

On October 14, 2025, Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

It is anticipated following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by Orthopaedics employment processes, programs, policies, and benefit plans. Details of any planned changes would be provided to you by Orthopaedics at an appropriate time and subject to any necessary consultation processes.

The Scientist II, Microbiological Quality & Sterility Assurance (MQSA) position is responsible for individual contributor execution of end-to-end implementation of contamination control and sterility assurance policies and strategies for MedTech Orthopedics and will assure that local programs are aligned with the overall J&J Microbiological Quality & Sterility Assurance policies. This role will support the MQSA responsibilities in Raynham, MA.

The Scientist II will serve as a technical contributor in the areas of microbiological quality, contamination control, cleaning, and sterilization. They will execute activities to support product manufacturing activities, product development, lifecycle management, and event resolution. They will contribute through the application of technical knowledge and expertise in contamination control, microbiological quality, aseptic processing, and sterilization processing. This position is responsible for compliance to applicable Quality Regulations and standards.

This is not meant as an all-inclusive list but top-level list of duties that this person generally completes. It is also understood that an associate may receive special projects outside of this list.

RESPONSIBILITIES:

Under supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

R &D –

• Provide input for the following for increasing complexity projects:
• Design for cleanability
• Design for decontamination
• Design for sterilizability
• Drive selection of sterilization modality, validation approaches and validation of the sterilization process.
• Generate sterilization product adoptions and validation documents.
• Support the implementation of new innovations in the areas of contamination control, terminal sterilization, and reprocessing, to include such activities as in participating in development of new products
• Provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally

Plan –

• Support the selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers)

Source –

• Provide sterility assurance and microbiological quality support for procurement activities that relate to sterile, non-sterile, or products requiring microbiological control that are externally manufactured
• Provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization and reprocessing standpoint
• Provide input for the design of critical utility systems and controlled environments to ensure that sterility assurance and microbiological quality requirements are maintained.
• Provide sterility assurance and microbiological quality support for audits of external vendors.

Make –

• Provide sterility assurance and microbiological quality control support to strategic MAKE initiatives.
• Support and execute sterile release of routine sterilization processes.
• Provide input into process risk assessments related to product cleanliness and sterility assurance
• Perform investigations for non-conformance/CAPA pertaining to product cleanliness and sterility assurance
• Work with internal and external laboratories to support sterility assurance testing requirements. Assure implementation of laboratory testing requirements for cleanliness and sterility assurance.
• Plan and execute product and process monitoring activities, including reporting of results in accordance with defined requirements.
• Provide support during internal and external audits of the MQSA organization.
• Evaluate changes to process and/or product to ensure that sterility assurance and microbiological quality requirements are maintained.

Internal Influencing –

• Interacts with business leaders to ensure objectives and project prioritization meet business needs. Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities.
• Participate on the J&J Sterility Assurance Councils as assigned or required for job function.
• Responsible for communicating business-related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

QUALIFICATIONS:

• A minimum of a bachelor’s degree within Microbiology, Biology, Engineering or related discipline. Preferably in life science discipline.
• A minimum of 2 years of experience in a medical device or pharmaceutical (combination) industry with a GMP and/or ISO regulated environment is required.
• Competent in using computer software such as Excel, Word and PowerPoint, and analytical software.
• Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility, required.
• Basic knowledge of associated regulations such as US FDA (QSR) regulations and ISO 13485 required.
• Basic knowledge in competent authority regulations and industry guidelines for environmental monitoring (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices is preferred.
• Good interpersonal and organizational skills are required.
• Must be able to effectively manage multiple tasks and projects.
• Comfortable to work with cross functional teams, required.
• Excellent communication skills - Written and Oral, required.
• Strong attention to detail is required.
• This position is located in Raynham, MA and may require up to 10% travel.

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 https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$69,500-$102,350

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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