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

Job Function:

Technology Enterprise Strategy & Security

Job Sub Function:

Solution Architecture

Job Category:

People Leader

All Job Posting Locations:

Irving, Texas, United States of America

Job Description:

We are searching for the best talent for a MES OT Lead to be 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

The MES OT Lead is responsible for the implementation, maintenance, and optimization of Manufacturing Execution Systems ( MES OT Lead ) across the organization. This role involves collaboration with various departments to ensure MES OT Lead solutions meet operational needs while driving efficiency and productivity. The MES and OT Lead is the 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.

This MES OT Lead position plays a crucial role in enhancing manufacturing efficiency and effectiveness by leveraging technology and data-driven insights.

SECTION 2: DUTIES & RESPONSIBILITIES*

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position is responsible for:

Key Responsibilities:

System Implementation:

• Lead the design, configuration, and deployment of MES solutions.
• Collaborate with IT and engineering teams to integrate MES with existing systems (ERP, Wonderware, etc.).
• 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.

System Maintenance:

• Ensure the MES is functioning correctly through regular maintenance and troubleshooting.
• Manage updates, patches, and upgrades to the MES software.

Process Optimization:

• Analyze manufacturing processes and identify areas for improvement using MES data.
• Implement and monitor key performance indicators (KPIs) to measure system performance.

Training and Support:

• Provide training and documentation for end-users on MES functionalities.
• Serve as the primary point of contact for MES-related issues and support.

Collaboration:

• Work closely with NPI, LCM, R&D, engineering, manufacturing, and quality assurance teams to ensure seamless integration teams to align MES capabilities with business needs.
• Facilitate communication between stakeholders to ensure successful project outcomes.

Project Management:

• Manage MES projects from initiation to completion, including scope definition, resource allocation, and timeline management within budget and no impact to quality or customer service.

• Prepare project documentation, including requirements, design specifications, and user manuals.

• 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. Quality Assurance:

• Establish process control protocols and quality assurance measures to ensure compliance with industry standards and regulations.

• Reviews, edits and finalizes technical documentation to verify compliance to technical specifications and standards.

• 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).

• 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).

Regulatory Compliance:

• Ensure that all MES processes are compliant with relevant regulations and internal policies, particularly in relation to safety, quality, and environmental considerations.

Environment, Health and Safety Compliance:

• Ensure compliance with safety regulations and promote a culture of safety within the manufacturing facility.
• Ensures 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.
• Supports corporate and site specific KPI’s on EHS are met.
• Acts as an SME for processes for which he / she is responsible.

Approvals

• Sign-off and approval of Purchase Orders to a pre-described maximum.
• Sign-off and approval of all production related documentation like S.O.P.’s, Quality Instructions, drawings, Concession and Non-Conforming Records (C.R. and N.C.R.)
• Sign off and approval of project documentation
• 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

SECTION 3: EXPERIENCE AND EDUCATION*

• Bachelor’s degree in Engineering, Computer Science, or a related field.
• An advanced degree, such as an MS or an MBA is preferred.
• Project Management and strong cross-functional business experience.
• 4+ years’ experience in manufacturing/design engineering.
• Experience in a manufacturing environment and/ or medical device industry preferred.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS *

Skills:

• Proficiency in MES software platforms (e.g., Siemens Opcenter, Rockwell FactoryTalk, etc.).
• 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)
• Excellent analytical and problem-solving skills.
• Strong project management and organizational skills.
• Outstanding communication and interpersonal abilities.
• Ability to work collaboratively in a cross-functional team environment.

Preferred Qualifications:

• Experience with system integration and data analytics.
• Familiarity with Lean Manufacturing principles and Continuous Improvement practices.
• Relevant certifications in project management or MES technologies.
• Knowledge on equipment validation documents (SOR, SRS, CSV, IQ or equivalent).
• Knowledge on GxP software validation (SDCL methodology).
• Six Sigma or Lean certification as Green Belt or Black Belt is preferred.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.