Systems Engineer Ii

hace 2 semanas

Ciudad Juarez, México Johnson & Johnson A tiempo completo

**We are searching for the best talent for Systems Engineer II to be in Juarez.**

**Purpose**:
The Systems Engineer is a technical expert on different MES software and related technology, capable of providing support and/or troubleshooting skills to solve problems to the different business units through the implementation of new/update MES configuration. Must be able to lead different projects related to MES (schedule, plan, forecast, resource and manage all the technical activities aiming at ensuring project accuracy and quality from conception to completion).

**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:

- Lead engineering projects ensuring that projects are completed on schedule and within budget with no impact to quality or customer service.
- Develop and execute detailed project plans using standard project management tools (Microsoft project, charter, Gantt chart, etc.).
- Prepare/review capital & expense forecasts for assigned projects. Prepare capital authorization requests (CAR).
- Controls project costs by approving and monitoring expenditures; administering contractor contracts.
- Report status on assigned projects in various formats to various organizational levels.
- Manage the NC and CAPA process by documenting, investigating, root cause analysis, and implementing corrective actions for product non-conformances.
- Ensure effective use of engineering and quality systems and adherence to quality system regulations (QSR).
- Follow the Ethicon design control process for all applicable projects.
- Perform process validations on new, transferred or modified processes for MES Implementation.
- Confirms product performance by designing and conducting tests and performs process validation on new, transferred or modified MES configuration.
- Ensure compliance to the quality policy in all activities.
- Maintains project integrity and reputation through compliance with state and federal regulations.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Maintains safe and clean working environment by enforcing procedures, rules, and regulations.
- Lead cross functional teams during investigations for MES Continues improvement.
- Responsible for supervising technicians in Manufacturing Engineering Systems.
- Other responsibilities may be assigned and not all responsibilities listed may be assigned- 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**
- Experience in a manufacturing environment and/ or medical device industry preferred.
- A minimum of Bachelor’s degree in an Engineering or Science discipline.
- Strong proven experience on MES software administration (Camstar, Rockwell, Traksys).
- Experience in Camstar configuration (WF, BOP, E-procedure,Task list, UDCD, queries)
- Strong experience on troubleshooting Personal Computers (PCs) and the different devices (drivers, controllers)
- B.S Engineering Degree or Science Discipline.
- Approximate experience, or equivalent knowledge and skills, necessary to satisfactorily perform the position responsibilities.
- 2 to 4 years’ experience in manufacturing/design engineering.
- Strong PC experience required.
- Experience in project management and good documentation practices.
- Experience in CAMSTAR Software configuration.
- Position requires excellent communication skills plus the ability to function in a team-based manufacturing environment.
- Bilingual: English/ Spanish.
- Knowledge of information systems including but not limited to JDE, Quality Systems & Documentation Control Systems.

Desired/Preferred Qualifications
- Six Sigma or Lean certification as Green Belt or Black Belt is preferred.
- Knowledge on equipment validation documents (SOR, SRS, CSV, IQ or equivalent).
- Knowledge on GxP software validation (SDCL methodology).
- Medical device or pharmaceutical industry experience
- Experience with OPC servers and/or WinCC (Kepware/Omniserver, etc.)

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