Microbiology Quality & Sterility Assurance (MQSA), Scientist

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:

Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of 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. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

DePuy Synthes, is recruiting for a Microbiology Quality & Sterility Assurance (MQSA), Scientist, located in West Chester, PA; Palm Beach Gardens, FL; Warsaw IN or Raynham, MA.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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.Key Responsibilities:

• 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.

Qualifications

Education:

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

Experience and Skills:

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.

Preferred:

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

Other:

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

Required Skills:

Preferred Skills:

Agility Jumps, Business Behavior, Compliance Management, Continuous Improvement, Database Backup, Data Gathering and Analysis, Data Savvy, Disruptive Innovations, Execution Focus, Issue Escalation, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

The anticipated base pay range for this position is :

$76,000.00 - $121,900.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits