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In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.

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Please visit https://www.jnjmedicaldevices.com/es-419 for more information.

Ethicon Endo-Surgery develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology, and surgical oncology. For more information, visit www.ethiconendosurgery.com

We are searching for the best talent for Sr. Sterilization Scientist to be in Juarez.

Purpose:

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 validation, compliance to applicable regulations and standards in the subject areas of sterility 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.

You will be responsible for:

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.

General -

1. Responsible for communicating business related issues or opportunities to next management level.

2. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

3. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

4. Performs other duties assigned as needed.

Qualifications

Requirements:

1. B.S. degree with Microbiology, Biology, Engineering or related scientific/technical discipline is required (an advanced degree is desirable).

2. A minimum of 4 to 6 years of experience in a medical device industry (terminal sterilization and industrial microbiology) with a GMP and/or ISO regulated environment is required.

3. Experience with validation of sterilization processes for medical products.

4. Experience in conducting audits of sterilization service providers and ancillary services impacting sterilization.

5. Personal computer skills, Excel, Word, PowerPoint and analytical software

6. Bilingual (English and Spanish).

7. Qualified candidate will have experience in microbiology, sterilization validation (terminal and/or reprocessing) and environmental controls for a medical device manufacturing facility.

8. Demonstrated competency in multiple healthcare and industrial terminal sterilization methods (e.g. EO, Radiation and Moist heat) is required.

9. Ability to troubleshoot process non-conformances and out of specification test results, and providing resolution to issues by a robust CAPA process

10. Experience in interacting with Regulatory Authorities is preferred

11. Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred.

12. Knowledge of relevant standards EU, USA and ISO is required

13. Oral and written skills and ability to communicate both up and down the business ladder within franchise or technical competency area is required

14. Demonstrated ability to work in a collaborative/teamwork environment is required

15. Independent organizational and time management skills is required.

16. Complete training in area of responsibility within allowed time period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures.

17. Complete required periodic re-training in areas such as safety & environmental.

18. Training plan requirements as identified in Corporate Training Procedure, CP0128.

19. Must be able to comply with established safety procedures and policies to maintain a safe working environment to ensure compliance with J&J environmental policies.