Expires soon Johnson And Johnson

Sterility Assurance Scientist

  • West Chester (Chester County)
  • Design / Civil engineering / Industrial engineering

Job description

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world.

DePuy Synthes offers an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we have created one organization that is agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

The Sterility Assurance Scientist is responsible for supporting activities that maintain compliance to the applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Regulation (MRD), ISO 13485, ISO 14971 and ISO 9001 as they apply to sterilization and reprocessing cleaning programs. Additionally, assists in ensuring compliance to other applicable Contamination Control, Endotoxin, Sterilization, Cleaning, and Microbial ISO standards, AAMI standards/reports and other guidance documents as required. Provides Sterility Assurance support to ensure the adequacy of activities and documentation in terms of regulatory compliance and technical soundness throughout the North American manufacturing system. This will be accomplished by working closely with Product Development, Packaging Technology, Regulatory Affairs, Operations and Quality organizations.

Position Duties & Responsibilities:

· Maintains procedures, tools and methodologies to cover sterilization and reprocessing cleaning programs.
· Obtains and maintains knowledge of FDA, ISO, and EN sterilization and related microbiology standards and guidelines, for example knowledge on ISO 11137, ISO 11135 and environmental monitoring requirements.
· Assists with technical assessments of contract sterilizers and laboratories.
· Helps to ensure adequacy of contamination control measures at external suppliers.
· Corresponds with customers and sales consultants as needed regarding sterilization and reprocessing cleaning information.
· Provides training to procedural changes.
· Provides input on the resolution of sterility related non-conformances.
· Supports sterilization validations, reprocessing cleaning validations, and supporting activities for all product families.
· Works with Product Development to ensure timely and complete sterilization adoptions and validations of all new products.
· Trains Product Development personnel in contamination control and sterilization requirements and procedures.
· Collaborates with Subject Matter Experts from other departments (e.g., Design Quality Engineering) to ensure a comprehensive approach to bring new and changed products into production.
· Creates and finalizes validation protocols and reports ensuring they are clear, concise and compliant.
· Knows and follows all laws and policies that apply to the position, and maintains the highest level of professionalism, ethics and compliance at all times.
· Diligently participates in compliance program-related activities.
· Executes other duties/responsibilities as assigned by manager.

Desired profile

Qualifications :

·  A minimum of a Bachelor Degree is required. A Bachelor Degree in Microbiology, Biological Sciences or Engineering is Preferred. Experience related to manufacturing and contamination control is Preferred
·  Minimum 2 years of sterilization/microbiological experience in the medical device, pharmaceutical and/or food industry is required.
·  Have working knowledge of applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Regulation (MDR), ISO13485, ISO 14971 and ISO 9001.
·  Familiar with government regulations and industry guidelines for sterilization and microbiological control.
·  Working knowledge of applicable software, particularly Microsoft Office applications, is required.
·  Strong collaboration and communication skills needed to effectively work on cross-functional project teams, interacting with a diversity of disciplines and locations.
·  Experience writing standard operating procedures, protocols, and test reports is preferred.
·  Basic understanding of microbiology, chemistry and engineering.
·  Strict attention to detail.
·  Must be able to work under pressure due to reporting deadlines.
·  Must be able to work with limited supervision.
·  Strong written and oral communication and interpersonal (listening) skills.
·  Familiarity with basic quality tools and techniques.
·  Analytical and critical thinking skills are important.
·  Excellent organizational and time management skills.
·  Willing to work in an international team.

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