At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https: //www.jnj.com/medtech

We are searching for the best talent for Senior Manufacturing Systems Engineer to be in Grecia, Costa Rica.

Purpose:

Performs non-standardized or uncommon tasks related to information system configuration, validation, maintenance, change management and installation of computer manufacturing systems and applications and their components; performs installation of systems; generates and drives tests in areas of Manufacturing, Quality, and Engineering. Develops, builds, inspects, calibrates, adjusts, verifies, improves, and maintains components related to the Manufacturing Execution System (MES). Performs tasks related to computerized system interfaces and databases.

You will be responsible for:

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 shop floor 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.
• 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 / Requirements:

• 4-6 years of experience in similar role.
• Bachelor’s degree 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 user documentation associated with the specific field.
• Advanced Language level: Spanish/English.
• Knowledge of GMP's (Good Manufacturing Practices) / ISO (Required)
• Knowledge in process and SDLC validation activities (Required)
• Knowledge of FDA regulations 21-CFR part 820 and Part 11 (Required).
• Knowledge of SQL DB (Preferably)
• Knowledge of programming tools (Python, Microsoft Apps, etc.) (Preferably)
• Knowledge in Manufacturing Systems (Required).
• Knowledge of ERP, CMMS, cPDM, Windchill, SAP (Required)
• Knowledge in Engineering Changes ECOs. (Required)
• Experience in medical industry (Required)