Mes Specialist I

MES SPECIALIST I

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 RESUME**

**RESPONSIBILITIES**
DUTIES & RESPONSIBILITIES*

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

- Representee of MES team to change request owner
- Supports shopfloor control team based on business impact
- Performs change intake process and understands requirements
- Performs change/impact assessments for MESDC
- Maintains and improves MES SOP’s
- Maps new processes or processes undergoing change
- Writes ECO’s, documents NR’s OBS, AP
- Takes voice of the customer and proposes internally how to improve processes
- Performs training and supports new hire introduction
- Participates in the administration and configuration of MES and connected systems.
- Coordinate and deliver training to MES users. Appendix I 100612422 Rev 8 CONFIDENTIAL use pursuant to Company Procedures Page 3 of 6
- Provides support in the development, testing, validation, and implementation of configurations of such systems.
- Provides support in the process of deploying the MES system to production, in aspects such as documentation, training of production personnel and problem solving in the same area.
- Provides sustaining support to the MES and connected systems
- Participates in the modification and maintenance of guidelines and procedures related to the areas of responsibility.
- Participates in the discussion of conceptual bases for the design and development of new configurations of manufacturing systems.
- Responsible for monitoring Interfaces related to the MES system.
- Participates in QA non-conformities and Observations.
- Collaborates in CAPA actions related to the MES system.
- Responsible for communicating business-related issues or opportunities to the next administrative level
- Responsible for ensuring that subordinates follow all of the Company's guidelines related to Health, Safety and Environmental practices and that all necessary resources to do so are available and in good condition.'
- Responsible for communicating business related issues or opportunities to next management level
- 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
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed

**Qualifications**:
**QUALIFICATIONS AND REQUIREMENTS**
- Studies in Technical Career or equivalent applicable to the area: Mechanical; Electrical; Electromechanical; Electronic; Information Technology; Industrial or system preferably.
- Knowledge and Skills to successfully develop the responsibilities of the position.
- Experience in conducting system integration test, user acceptance test and production rollout Preferably.
- Experience in user problem understanding, requirements gathering, analysis, design, and solution proposal preferably.
- Extensive knowledge in computational packages.
- Excellent verbal and written communication skills including the ability to write technical documentation and communicate technical information to non-technical audiences.
- Ability to read and understand technical documentation associated with the specific discipline.
- Advanced Language level: Spanish/English.
- Knowledge of GMP's (Good Manufacturing Practices) / ISO (Preferably)
- Knowledge in process and SDLC validation activities (Preferably)
- Appendix I 100612422 Rev 8 CONFIDENTIAL use pursuant to Company Procedures Page 4 of 6
- Knowledge of FDA regulations 21-CFR part 820 and Part 11 (Preferably).
- Knowledge of SQL DB (Preferably)
- Knowledge of programming tools (Python, Microsoft Apps, etc.) (Preferably)
- Knowledge in CAMSTAR (Preferably).
- Knowledge of JDE, CMMS, cPDM, Windchill, SAP (Preferably)
- Knowledge in Engineering Changes ECOs. (Preferably)
- Experience in medical industry (Preferably