Posted: Friday, January 26, 2018 3:33 PM
DePuy Synthes Companies of Johnson & Johnson is seeking a Supervisor, 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 will 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, we are creating one organization that will be 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 Supervisor, Sterility Assurance leads and executes sterility assurance support for medical device manufacturing in the Raynham facility. You will set the tactical direction for sterility assurance support 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.
Key responsibilities include:
- Develop and 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
- Apply best practices in sterilization validation, revalidation, and troubleshooting in accordance with applicable regulations and standards.
- Ensure manufacturing process changes are in compliance and meet contamination control and sterility assurance requirements
- Manage and disposition contamination control or sterilization CAPAs and non-conformances, including root cause identification and corrective action implementation
- Provide Sterility Assurance support during facility audits
- Manage technical assessments of third party manufacturers, sterilization contractors, external laboratories and other applicable suppliers.
- Drive innovation to provide novel methodologies, processes or strategies for contamination control and sterilization.
- Manage the performance and development of individuals dedicated to manufacturing support activities.
- Lead the sterile release program
- A minimum of a Bachelorâs degree in microbiology, biology, engineering, or equivalent discipline.
- 5+ years of experience in a medical device, pharmaceutical, or similar regulated industry.
- A minimum of 2 years of supervisory experience is preferred.
- 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 and experience in interacting with Regulatory Authorities is required.
- Must have a deep understanding of contamination control for manufacturing processes and product/cleanroom environment testing programs.
- Knowledge of purified water systems and product cleaning processes is preferred.
- Demonstrated 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.
- Excellent organizational and time management skills.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.Johnson&JohnsonFamilyofCompaniesareequalopportunityemployers,andallqualifiedapplicantswillreceiveconsiderationforemploymentwithoutregardtorace,color,religion,sex,sexualorientation,genderidentity,geneticinformation,nationalorigin,protectedveteranstatus,disabilitystatus,oranyothercharacteristicprotectedbylaw.
Depuy Orthopaedics. Inc. (6029)
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=0154180118&lang=en
• Location: South Coast
• Post ID: 55376737 southcoast