Johnson & Johnson Careers
Sterility Assurance Scientist
Requisition ID: 0132180819
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.
The Scientist, Sterility Assurance executes sterility assurance support for medical device manufacturing in the Raynham facility, through the application of technical knowledge and expertise in contamination control, sterilization processing and industrial microbiology, ensuring compliance to applicable Quality and Sterilization Regulations and standards.
The key position responsibilities include:
- Maintain local or facility-specific procedures for contamination control and sterility assurance in accordance with franchise, corporate and applicable international standards
- Manage product bioburden/dose audit/endotoxin routine testing program and cleanroom environment/purified water systems routine testing programs including defining product families, investigating aberrant results and causes, and developing and implementing corrective actions.
- Provide Sterility Assurance support to Manufacturing, including defining testing requirements for contamination control and sterilization validation of product or process changes, investigation of non-conformances, implementation of corrective actions, and recommending product dispositions.
- Develop protocols and coordinate with contract sterilizers/laboratories to execute sterilization validations and revalidations.
- Manage and disposition contamination control or sterilization CAPAs and non-conformances, including root cause identification and corrective action implementation
- Perform risk assessments of manufacturing processes (e.g. bioburden, endotoxin, residual contamination, process interventions).
- Drive innovation to provide novel methodologies, processes or strategies for contamination control and sterilization.
- Individual must have a minimum of a bachelor’s degree in microbiology, biology, engineering, or equivalent discipline
- A minimum 2 years of experience in a medical device, pharmaceutical, or similar regulated industry.
- Industry expertise in radiation sterilization is required.
- Experience with ethylene oxide sterilization and steam sterilization is preferred.
- Detailed knowledge of working in a quality environment with related international standards is required.
- Must have a strong understanding of contamination control for manufacturing processes and product/cleanroom environment testing programs.
- Knowledge of purified water systems and product cleaning processes is preferred.
- The individual must have demonstrated strong teamwork and communication skills to work effectively on cross-functional project teams, interacting with a diversity of disciplines such as Manufacturing, Manufacturing Engineering, Quality Engineering, Regulatory Affairs, etc.
- Analytical and critical thinking skills are required. Must have excellent organizational and time management skills.
Depuy Orthopaedics. Inc. (6029)