Senior Scientist, MQSA.

Job content

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo

Senior Scientist, Microbiological Quality & Sterility Assurance

DePuy Synthes

Position Overview

DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.

We are currently seeking to bring a Senior Scientist, Microbiological Quality & Sterility Assurance to support a large portfolio of innovative medical devices across. This position supports end -to -end microbiology and sterility assurance research and development for global orthopedics. Our MQSA research and development team focuses on cleaning and disinfection requirements, sterilization validation, device processing, microbiological testing to support the validation and maintenance of the sterilization processes and product label claims. We are currently looking for an enthusiastic and innovate scientist with the following profile.

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Tasks & Responsibilities

• Responsible for end-to-end Microbiological Quality and Sterility Assurance (MQSA) of new product development and sustainment of commercial products within Johnson & Johnson Global Orthopedics
• Supports the regulatory approval of sterile and non-sterile new products, including internal research & development products, new acquisitions, licensing, and strategic partnerships
• Leads, owns and provides subject matter expertise to corrective and preventive actions, non-conformances, audit observations and risk assessments
• Works with internal and external laboratories to support microbiological and sterility assurance testing requirements
• Collaborates internally and externally to provide input to standards associations (e.g., AAMI, ISO), influencing regulations and standards
  
  

Qualifications

• A minimum of an undergraduate (BS) degree in Microbiology, Biology, Engineering, or related discipline
• A minimum of 4 years of combined experience in medical device, pharmaceutical or related regulated industry
• Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility
• Demonstrated competency in terminal sterilization, device processing, and microbiological quality
• Leading, coaching, mentoring and/or influencing capacity
  
  

Our Offer

• An exciting position in an international and dynamic environment with continuous learning and growth opportunities
• A competitive salary, health/energy programs and other benefits.
• An inclusive team environment where diversity and different opinions are respected and valued, and the importance of a good work-life balance is recognized.
  
  

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location

Switzerland-Solothurn-Zuchwil-

Other Locations

North America-United States-Massachusetts-Raynham, North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-Warsaw

Organization

Synthes GmbH (7111)

Job Function

R&D

Requisition ID

2105981397W