DePuy Synthes, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist, Sterility Assurance to be located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer 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, more agile and better equipped to meet the needs of 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 Scientist will represent the Sterility Assurance Department on cross-functional new product development teams, focusing on sterilization validation of the new products, and will support Manufacturing. The Scientist will:
• Provide input to product design for sterilizability and determine sterilization validation requirements for products to be sold sterile.
• Assess reusable devices for cleaning and sterilization validation requirements and/or equivalency to existing products.
• Manage testing with contract sterilizers and microbiology testing laboratories and will analyze data and write validation test reports
• Evaluate product or manufacturing process changes and define sterilization validation testing requirements.
• Investigate sterilization non-conformances, determine a root cause, and develop corrective actions within due dates.
• Provide sterilization technical support for audits of contract sterilizers.
• Interface with Regulatory Authorities during on-site inspections and for product submissionsQualifications
• A minimum of a Bachelor’s degree in Life Sciences or equivalent is required.
• A focused degree in Microbiology is preferred.
• A minimum of 3 years’ experience in a regulated industry is required
• Experience in at least one sterilization method is required.
• Experience and knowledge of hospital cleaning and sterilization practices is preferred.
• Strong teamwork and communication skills to work effectively on cross-functional project teams are required.
• Knowledge of ISO sterilization standards is strongly preferred.
• Strong writing skills with the ability to write standard operating procedures, protocols, and test reports are required.
• Results oriented and able to multi-task, along with decision-making and problem-solving skills are also required.
• This position will be located in Raynham, MA and may require up to 20% domestic and international travelPrimary Location
Depuy Orthopaedics. Inc. (6029)Job Function