Principal Scientist

Company: Disability Solutions
Location: Santa Clara
Posted on: March 16, 2023

Job Description:

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Principal Scientist, located in Santa Clara, CA or Cincinnati, OH! This position is available for relocation assistance. Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com The Principal Sterilization Scientist MQSA provides technical leadership within the RAD business. This position requires translation of product Microbiological and Sterility Assurance (MQSA) quality requirements into product sterility and process improvements. The position requires an investigative approach by applying strong MQSA principles to deliver effective solutions to achieve regulatory requirements over a broad range of national and international standards. Responsible for root cause identification as well as implementation of improvements. Accountable for developing technical solutions to drive improvements in activities such as: Non-conformances and CAPAs. Accountable for leading the design and validation of reusable device cleaning and disinfection validations and sterilization process validations for new products. Responsible the E2E MQSA functions supporting marketed sterile single use & reusable medical device products. Key Responsibilities:

• Collaborate with various project teams (R&D, Quality, Operations and Regulatory Affairs) and provide subject matter expertise for product lifecycle management.
• Drive compliance to existing and emerging regulatory standards in the areas of device reprocessing, scope reprocessing, cleaning and disinfection of capital equipment and terminal sterilization of devices.
• Support the selection and assessment of contract laboratories as it relates to the E2E sterility assurance for products.
• Provide technical support for procurement related activities for all products or components that are externally manufactured.
• Provide direct support to the extended sterility assurance team in the IQ, OQ and PQ of controlled manufacturing environments for Auris Health products.
• Provide primary microbiological SME input in maintaining sterility assurance level (SALs) for Auris Health products and maintain substantiated sterilization validations (PQ, MPQ and PPQ) working directly with operations team (internal/external).
• Coordinate sterilization validation and requalification sample testing through packaging facilities & approved laboratories, trend data and preparing reports.
• Develop test protocols, carry out experiments (including design of equipment/fixtures as needed), analyze test results, and prepare technical reports.
• Serve as the primary technical liaison for external contract laboratories and external manufactures.
• Responsible for technical investigation for any non-conformities to the process.
• Accountable for driving technical improvements in activities such as: Non-conformances and CAPAs.
• Ensure all industrial microbiological requirements are compliant to current industry standards and regulatory requirements.
• Responsible for writing instructions for use specific to reusable medical devices and capital equipment processing and execution of validations to support.
• Network with the internal and external scientific, technical, and regulatory communities to maintain state-of-the-art knowledge.

Keywords: Disability Solutions, Santa Clara , Principal Scientist, Other , Santa Clara, California