**Senior Sterility Assurance Scientist**
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**COMPANY**
**JOB SUMMARY**
The Senior Sterility Assurance Scientist is responsible for providing expert technical/business
leadership to development teams & operations in areas of end to end contamination control and
sterility assurance policies for the manufacturing of products within Ethicon Endo-Surgery
MedTech MQSA organization.
The Senior Sterility Assurance Scientist technical areas supported include: sterilization
validation (EO and Gamma), reprocessing, microbiological testing to support the validation and
maintenance of the sterilization processes and product label claims (e.g. bioburden, test of
sterility, endotoxin monitoring), environmental control and monitoring, water and air systems
assurance and laboratories.
As applicable evaluate technical & regulatory requirements against business needs in
development & maintenance of corporate level policies, procedures & strategies impacting all
Ethicon Endo-Surgery sterile single use & reusable products, facilities and contractors.
**RESPONSIBILITIES**:
Under limited supervision and in accordance with all applicable federal, state and local
laws/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) to
ensure manufacturing associated design changes are in compliance to meet
microbiological quality and sterility assurance requirements
2. Support the transfer of new innovative test methods and practices in the areas of
terminal sterilization and industrial microbiology.
3. Work directly with MQSA peers to support development and transfer of break-through
technologies.
4. Work directly with project leaders to define product and sterilization needs for Ethicon
Endo-Surgery products including the validation of those needs.
Plan
- 1. Support operating company in maintaining regulatory readiness
2. Provide support in the development of new manufacturing operations (to include
manufacturing sites and facility investments, contract sterilization & laboratories, and
third party manufacturers).
Source
- 1. Provide technical SME support for procurement activities that relate to sterile, non-sterile
or microbiologically controlled products that are externally manufactured.
2. Support requirements for new manufacturing processes, controlled environments and
packaging from a microbiological, terminal sterilization and reprocessing.
3. Provide technical SME support for sterility assurance and contamination control in
supplier audits.
Make
- 1. Support cross functional compliance to the end-to-end sterility assurance policies at
defined manufacturing facilities.
2. Collaborate with various groups, provide microbiological SME input and support lifecycle
management to ensure product/process changes meet contamination control and sterility
assurance requirements.
3. Support the investigation, gap analysis, and develop corrective action plan for
microbiological or contamination control CAPAs and non-conformance, including root
cause identification and corrective action implementation within agreed timelines (Use
As 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 testing
requirements (quarterly dose audit samples).
7. Serve as the primary technical liaison for external contract laboratories and external
manufacturers.
Deliver
- 1. Ensure all industrial microbiological requirements are compliant to current industry
standards and regulatory requirements.
External Influencing
- 1. Develop knowledge on best practices in sterility assurance and contamination control by
interacting with JJSA leadership.
Internal Influencing
- 1. Interact with product development teams to ensure objectives and project timelines meet
business needs. Interact with peers in sterility assurance to utilize resources and ensure
best practices across facilities.
1. Responsible for communicating business related issue
