DePuy Synthes Companies of Johnson & Johnson is seeking a Sterility Assurance Senior Scientist to be located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies 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.
Responsible for implementation and management of sterility assurance and reprocessing cleaning programs. Ensures compliance to the applicable FDA (QSR) regulations, Canadian Medical Device Regulation (CMDR), Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001 as they apply to sterilization and reprocessing cleaning programs. Additionally, ensures compliance to other applicable Endotoxin, Sterilization, Cleaning, and Microbial ISO standards, AAMI standards/reports and other guidance documents as required. Provides Sterility Assurance oversight 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, Material Sciences, Regulatory Affairs and Quality organizations.
POSITION DUTIES & RESPONSIBILITIES
Establish and maintain procedures, tools and methodologies to cover sterilization and reprocessing cleaning programs. Maintain 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. Conduct technical assessments of contract sterilizers and laboratories. Train Sterility Assurance personnel to ensure program requirements are met. Correspond with customers and sales consultants as needed regarding sterilization and reprocessing cleaning information. Provide guidance and training to Sterility Assurance sterile release personnel. Provide input on the resolution of sterility related non-conformances. Ensure sterilization validations, reprocessing cleaning validations, and supporting activities for all product families are maintained. Other duties/responsibilities as assigned by manager.
Product Development Support Responsibilities: Work with Product Development, Synthes Europe, and vendors to provide appropriate guidance to communicate Sterilization program product family details such that new product concepts can fit into these programs if possible. Work with Product Development to ensure timely and complete sterilization adoptions and validations of all new products. Train Product Development personnel in sterilization procedures. Collaborate with Subject Matter Experts from other departments (e.g., Packaging Technology) to ensure a comprehensive approach to bring new and changed products into production. Provide guidance to Product Development and plant personnel as required ensuring clear, concise and defensible protocols and reports are generated.
Compliance Responsibilities: Know and follow all laws and policies that apply to one's job, and maintain the highest level of professionalism, ethics, and compliance at all times. Diligently participate in compliance program-related activities as denoted by management and the Chief Compliance Officer.