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**Senior Sterility Assurance Scientist**

At Johnson & Johnson, we strive to revolutionize healthcare by harnessing the power of innovation and diversity.

Our commitment to inclusivity has enabled us to make a profound impact on the lives of over 1 billion patients and consumers every day for over 130 years.

We welcome individuals from all backgrounds to contribute to our mission of changing the trajectory of health for humanity.

**COMPANY**

**JOB SUMMARY**

The Senior Sterility Assurance Scientist is responsible for providing expert technical leadership to development teams and 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 and regulatory requirements against business needs in the development and maintenance of corporate level policies, procedures, and strategies impacting all Ethicon Endo-Surgery sterile single-use and 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 breakthrough 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 perspective.

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 issues