MES OT Lead

Johnson & Johnson•Irving, TX

23h

About The Position

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Johnson & Johnson is recruiting for a MES OT Lead to join our team in Irving, TX. 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 Purpose: The MES and OT Lead 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).

Requirements

4-7 Years of Experience
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, JDE, SAP, Kepware, Wonderware).Experience in Camstar configuration (WF, BOP, E-procedure, Task list, UDCD, queries, etc.)
Strong experience on troubleshooting Personal Computers (PCs) and the different devices (drivers, controllers)
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.
Knowledge of information systems including but not limited to JDE, Quality Systems & Documentation Control Systems.

Nice To Haves

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 middleware software (Kepware/Wonderware, etc.)

Responsibilities

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).
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 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 Technician MES.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
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.