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Senior Sterilization Scientist
Requisition ID: 9649180115
Ethicon Inc, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Sterilization Scientist, located in San Angelo, TX.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Please visit https://www.ethicon.com/na/ for more information.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Sterilization Scientist is responsible for providing expert technical / leadership to development teams & operations in area of sterilization. Functioning as an Ethicon, Inc. technical expert in sterilization & microbiological areas.
- Evaluating technical & regulatory requirements against business needs in development & maintenance of corporate level policies, procedures & strategies impacting all Ethicon sterile single use & reusable products, facilities & contractors. Supervise technical personnel either reporting full time or on temporary assignment to facilitate sterilization validations, troubleshooting or sterilizer operations.
- Input sterilization validation requirements into team schedules to insure team goals are met. Coordinate microbiological testing with approved laboratories to support teams.
- Coordinate exposure of test samples to sterilization processes to support teams.
- Advise operations (internal & suppliers) on environmental monitoring practices for manufacturing environments. Determine appropriate DDS strategies for complex product / orientations with possible assistance of more senior level associates.
- Advise QS, RA & Product Inquiry on specific sterilization / microbiology questions.
- Trouble-shoot sterilization process deviations & develop short & long-term solutions to prevent reoccurrence with possible assistance of more senior level associates.
- Manage projects of various size & complexity, but complex projects with high impact to organization will be primary focus.
- Optimize sterilization operations through development of innovative & cost-effective sterilization specifications & procedures. Serve as lead in managing projects involving technical associates reporting on temporary assignment to facilitate sterilization validations, troubleshooting or sterilizer operations.
- Develop & implement corporate sterilization validation policies & procedures.
- Lead company teams to accomplish sterilization & microbiological related projects.
- Serve as sterility assurance Subject Matter Expert (SME) for site
- Provide technical guidance & consultation to Ethicon plants & other J&J Companies.
- A minimum of a Bachelor’s of Science (Life Science, Chemical Engineering, Biomedical) or relevant degree is required. An advanced degree is a plus.
- A minimum of 6 years of direct experience with medical device, pharmaceutical, or related sterilization processes is required
- Specific course work in Microbiology is desirable
- Direct experience in validation & development of ethylene oxide processes is required
- Prior experience working with Cobalt gamma sterilization processes is preferred
- Familiarity with product packaging requirements, product functionality & stability requirements & biocompatibility requirements is desired
- Knowledge of the following is strongly preferred:
- Association for the Advancement of Medical Instrumentation (AAMI)
- International Organization for Standardization (ISO)
- Radiation Sterilization Standards
- AAMI / ISO Industrial Ethylene Oxide Sterilization Standard
- Microbiological procedures related to sterilization process validation
- Radiation dosimetry systems – routing measurements & calibration
- Environmental monitoring experience is required
- The ability to manage multiple projects simultaneously is required
- This position could require up to 10% both domestic and international travel
United States-Texas-San Angelo
Ethicon Inc. (6045)