Manufacturing Execution System (MES) Lead

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way. Learn more at is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology immunology and neuroscience. J&Js significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

The GET (Global Engineering & Technology) organization operates as one integrated team in the delivery of Engineering Maintenance and Execution Systems solutions. We operate in a standard coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.

Apply today for this great opportunity located in Wilson NC!

The MES Lead drives the design and configuration activities of sites Kroeber PAS-X MES including MBR design vendor management production validation and development systems system standards and interfaces to DCS & IT systems.

The new facility and the production process are envisioned to be highly automated with data being shared across multiple platforms to support production from raw material receipt to disposition of the produced drug substance. Data generated at each stage of production will be shared across business information and control systems including the multivariate analysis to support predicative models for process control and disposition support.

Key Responsibilities:

• lead the design deployment and continues improvement of site MES

• Oversee technical team of vendors and contractors to ensure requirements are implemented and tested correctly

• Collaborate cross-functionally with Manufacturing Quality Engineering and IT to identify and implement digital solutions that enhance productivity and data accuracy.

• Lead the planning execution and completion of MES application configuration activities like MBR item management equipment management label management from start to finish. This includes defining project scope creating technical designs and managing project execution.

• Work hand on hard with IT in seamless integration of the MES with other enterprise and shop floor systems such as ERP SCADA and LIMS to enable real-time data flow.

• Provide in-depth technical support and troubleshooting for MES-related issues including troubleshooting configuration errors and integration challenges with DeltaV. Develop and maintain technical documentation.

• Ensure that site and global standards are met.

• Lead risk assessments.

• Support GMP audits.

Qualifications

Education:

• Bachelors degree in engineering IT Science or related field; required

Experience and Skills:

Required:

• A minimum of 8 years of experience in a manufacturing environment biopharmaceutical or pharmaceutical industry or an equivalent combination of education and experience

• In-depth knowledge of MES platforms (e.g. Werum PAS-X) and interfaces to IT and DCS.

• Proficiency in MES software platforms with strong programming skills in areas SQL PL/SQL and Java. Expertise with OPC servers and clients for data exchange is also valuable.

• Strong analytical and problem-solving skills to handle complex technical challenges and provide effective solutions.

• Proven ability to lead technical teams manage projects and mentor junior engineers.

• Excellent communication skills to effectively present technical information to both technical and non-technical audiences and to gather requirements from clients.

• Knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11.

• Proven experience within a pharmaceutical or GMP regulated manufacturing environment

• Experience in supervision/management of people and resources.

• Process knowledge for Upstream Downstream and Bio Processing Support functions.

Preferred:

• Good appreciation of Industry 4.0/IoT

• Experience in integrating MES system with DeltaV PAS & OSI PI data historian

• Good understanding of batch release reports and release by exception

Other:

• Ability to travel up to 10% of the time domestic and internationally

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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 & 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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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