**Senior Sterility Assurance Scientist**At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough.**COMPANY****JOB SUMMARY**The Senior Sterility Assurance Scientist is responsible for providing expert technical/businessleadership to development teams & operations in areas of end to end contamination control andsterility assurance policies for the manufacturing of products within Ethicon Endo-SurgeryMedTech MQSA organization.The Senior Sterility Assurance Scientist technical areas supported include: sterilizationvalidation (EO and Gamma), reprocessing, microbiological testing to support the validation andmaintenance of the sterilization processes and product label claims (e.g. bioburden, test ofsterility, endotoxin monitoring), environmental control and monitoring, water and air systemsassurance and laboratories.As applicable evaluate technical & regulatory requirements against business needs indevelopment & maintenance of corporate level policies, procedures & strategies impacting allEthicon Endo-Surgery sterile single use & reusable products, facilities and contractors.**RESPONSIBILITIES**:Under limited supervision and in accordance with all applicable federal, state and locallaws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:This individual will be responsible for activities such as, but not limited to, the following:R&D- 1. Collaboration with various groups (R&D, Quality, Operations and Regulatory Affairs) toensure manufacturing associated design changes are in compliance to meetmicrobiological quality and sterility assurance requirements2. Support the transfer of new innovative test methods and practices in the areas ofterminal sterilization and industrial microbiology.3. Work directly with MQSA peers to support development and transfer of break-throughtechnologies.4. Work directly with project leaders to define product and sterilization needs for EthiconEndo-Surgery products including the validation of those needs.Plan- 1. Support operating company in maintaining regulatory readiness2. Provide support in the development of new manufacturing operations (to includemanufacturing sites and facility investments, contract sterilization & laboratories, andthird party manufacturers).Source- 1. Provide technical SME support for procurement activities that relate to sterile, non-sterileor microbiologically controlled products that are externally manufactured.2. Support requirements for new manufacturing processes, controlled environments andpackaging from a microbiological, terminal sterilization and reprocessing.3. Provide technical SME support for sterility assurance and contamination control insupplier audits.Make- 1. Support cross functional compliance to the end-to-end sterility assurance policies atdefined manufacturing facilities.2. Collaborate with various groups, provide microbiological SME input and support lifecyclemanagement to ensure product/process changes meet contamination control and sterilityassurance requirements.3. Support the investigation, gap analysis, and develop corrective action plan formicrobiological or contamination control CAPAs and non-conformance, including rootcause identification and corrective action implementation within agreed timelines (UseAs Is for release of product).4. Support technical assessments of third-party manufacturers, sterilization contractors,external laboratories and other applicable suppliers.5. Provide technical support during on-site inspections.6. Work with internal and external laboratories to support sterility assurance testingrequirements (quarterly dose audit samples).7. Serve as the primary technical liaison for external contract laboratories and externalmanufacturers.Deliver- 1. Ensure all industrial microbiological requirements are compliant to current industrystandards and regulatory requirements.External Influencing- 1. Develop knowledge on best practices in sterility assurance and contamination control byinteracting with JJSA leadership.Internal Influencing- 1. Interact with product development teams to ensure objectives and project timelines meetbusiness needs. Interact with peers in sterility assurance to utilize resources and ensurebest practices across facilities.1. Responsible for communicating business related issue
