Mentor part of the Johnson & Johnson Medical Devices Companies is recruiting for a Senior MES Process Engineer for Mentor Irving manufacturing facility in Irving, TX
Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.
The Senior MES Process Engineer will serve as the System Owner of the Manufacturing Execution System (MES) for Mentor Irving manufacturing facility in Irving, TX. The successful candidate will have demonstrated proficiency in leading MES deployment and system administration, implementing complex electronic Manufacturing Batch Records and integration of MES with related business and automation systems.
Under limited direction, responsible for managing all operations related to manufacturing, materials, facilities, distribution, engineering and maintenance to ensure smooth, continuous, cost effective and controlled manufacture of products in support of the business forecasts and inventory goals.
- The role of Senior MES Process engineer is to provide engineering support for manufacturing operations specifically in modeling and workflow creation using Camstar MES system.
- The role requires technical knowledge of MES and ability to link process steps and contributing towards key business drivers such as Quality, Safety, Production and Cost.
- As an MES modeling owner, the role will involve collaborating with a number of functional groups delivering projects in the value stream such as New Production Introductions, process improvement and manufacturing engineering.
DUTIES & 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:
- Translate process requirements and MES system best practices into practical, usable electronic batch records
- Support design requirements, functional specifications, and computer system validation strategy
- Lead MES integration with process/test equipment and other electronic business and automation systems
- Collaborate with vendors (as part of a team) to define user requirements and ensure the system design meets business requirements. Develop business processes, guidelines, Work Instructions and SOPs to support the MES systems
- Provide leadership to the site as the point of contact for MES and collaborate with IT, Quality, Supply Chain, Manufacturing, Process Development to drive continuous improvements using MES
- Partner with internal departments & external vendors to assist in commissioning and updating the MES system.
- Document requirements, process flows, new functionality, and creation of SOP/training materials while maintaining all materials and configured software in applicable servers
- Participate in the development of MES system life cycle strategy and business/technical processes for change management. Training super and end users on functionality and process changes as they relate to MES
- Trouble shooting daily operational system issues to define root cause, working in collaboration with Manufacturing, Quality and MESf CoE to build temporary/permanent solutions
- Administration and maintenance of site MES Production and offline system
- Demonstrate strong leadership and a clear identifiable work ethos within the Manufacturing Engineering team.
- Support the implementation of all engineering and plant strategic initiatives.
- 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.
- Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
- Performs other duties assigned as needed.
- Bachelor’s Degree: in Computer Science, Information systems, Engineering, or related field
- 2 years minimum industry experience in systems or process development, programming, and process automation
- 2 years minimum experience working within Camstar MES applications (Manufacturing Execution Systems)
- Experience in MES deployment is highly preferred
- Perform requirement analysis and design for the new development.
- Conduct discussions and get necessary approvals for all the architecture design from the client architects and business analysts.
- Provide estimates, planning and scheduling the timelines for the development activities.
- Develop server-side business logic using Camstar Designer
- Strong experience in Camstar MES Modeler/Designer and Camstar Portal
- Development/implementation Experience in Camstar Interoperability
- Perform code review, unit test plan preparation and subsequent unit testing. Investigating and resolving bugs across the application
- Provide System Testing & User Acceptance Testing support
- Coordinate Implementation with all the stakeholders involved
- Exposure to MES technologies, including automated data collection, historian applications (OSI PI a plus). SCADA, automated decision control, workflow, database applications, and interface to ERP and LIMS systems
- Competent communication skills, both written and verbal are required.
- Technical writing skills preferred.
- Exposure to software IQ/OQ/PQ preferred.
- Good organizational skills and the ability to handle multiple tasks required.
- Less than 5% of domestic and international.
ADDITIONAL POSITION REQUIREMENTS
- Ability to work 8 am – 5 pm shift, including weekends and overtime as needed is required.
- Preferred strong skills in programming tools, like C#.NET, ASP.NET, VB.NET, and Microsoft SQL and Reporting Services
- Preferred experience with Wonderware
PHYSICAL WORKING CONDITIONS / REQUIREMENTS
- Required Physical demands of the position include stooping, walking, pulling, light lifting (up to 25 lbs.), grasping, hearing, visual acuity, kneeling, reaching, pushing, talking, standing, fingering and crawling.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Mentor Texas LP (6182)