Senior Scientist

hace 3 semanas

Ciudad Juarez, México Johnson & Johnson A tiempo completo

**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/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

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