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Senior Scientist
hace 2 semanas
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.
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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
microbiological quality and sterility assurance requirements
- Support the transfer of new innovative test methods and practices in the areas of
- Work directly with MQSA peers to support development and transfer of break-through
- Work directly with project leaders to define product and sterilization needs for Ethicon
Plan
- 1. Support operating company in maintaining regulatory readiness
- Provide support in the development of new manufacturing operations (to include
third party manufacturers).
Source
- 1. Provide technical SME support for procurement activities that relate to sterile, nonsterile
- Support requirements for new manufacturing processes, controlled environments and
- Provide technical SME support for sterility assurance and contamination control in
Make
- 1. Support cross functional compliance to the endtoend sterility assurance policies at
- Collaborate with various groups, provide microbiological SME input and support lifecycle
assurance requirements.
- Support the investigation, gap analysis, and develop corrective action plan for
cause identification and corrective action implementation within agreed timelines (Use
As Is for release of product).
- Support technical assessments of third-party manufacturers, sterilization contractors,
- Provide technical support during on-site inspections.
- Work with internal and external laboratories to support sterility assurance testing
- Serve as the primary technical liaison for external contract laboratories and external
Deliver
- 1. Ensure all industrial microbiological requirements are compliant to current industry
External Influencing
- 1. Develop knowledge on best practices in sterility assurance and contamination control by
Internal Influencing
- 1. Interact with product development teams to ensure objectives and project timelines meet
best practices across facilities.
- Responsible for communicating business related issue
-
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