Senior Manager, Manufacturing Execution Systems (MES) and Automation 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

Job Function:

Technology Product & Platform Management

Job Sub Function:

Multi-Family Technology Product & Platform Management

Job Category:

People Leader

All Job Posting Locations:

Raritan New Jersey United States of America

Job Description:

About Innovative Medicine

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 are searching for the best talent for a Senior Manager Manufacturing Execution Systems (MES) and Automation Lead to join our team. This is an onsite position located in Raritan NJ.

Are you interested in joining a team that is positively impacting patients lives by ensuring high quality and reliable supply of our cell therapy products Apply today for this exciting opportunity to be part of the #CAR-T team!

Johnson & Johnson Innovative Medicines and Legend Biotech have entered into a global strategic collaboration to develop manufacture and commercialize a chimeric antigen receptor (CAR) T-cell therapy for BCMA. This strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform treatment.

Overview

We are seeking a Senior Manager Site MES and Automation Lead to oversee the Manufacturing Execution Systems (MES) and manufacturing automation team for at the Raritan CART facility. This role combines team leadership with deep technical expertise in MES/OT/automation and regulated system validation. The role will own MES architecture deployments validation and operations that support the manufacturing workflows (chain of identity/custody) and integration with QC/LIMS and ERP systems to ensure product quality compliance and ontime delivery.

Key Responsibilities

• Provide direct leadership to a team of systems engineers and technology professionals fostering a positive work culture that empowers employees and cultivates high-performance teams. This includes establishing hiring priorities training plans and performance objectives.

• Lead MES and automation strategy for the CART site including roadmap standards architecture and governance aligned to manufacturing and quality requirements.

• Own endtoend delivery of MES projects: including requirements design integration commissioning CSV (IQ/OQ/PQ) and lifecycle support.

• Implement CART process changes into MES functionality: patient lot tracking chain of identity and chain of custody electronic batch records (EBR/EBR templates) recipe management deviations/CAPA integration and audit trails.

• Implement industrial cybersecurity and OT controls consistent with regulatory and company policies. Corporate IT/cyber teams for secure OT/IT convergence.

• Deliver MES support for controlled materials handling: lot and reagent traceability barcode/RFID systems label generation and controlled dispensing workflows.

• Partner closely with Quality Manufacturing and MSAT to define requirements prioritize roadmap items and ensure operational readiness.

• Lead change management training and golive support to ensure user adoption and sustained operation of MES capabilities.

• Represent the MES function during regulatory inspections and audits.

Qualifications

Education:

• A minimum of a Bachelors degree is required preferably with a focus in Science or Engineering. Masters or higher degree is preferred.

Required:

• 10 years experience in manufacturing automation MES and OT/IT integration; minimum 5 years in regulated pharma/biotech manufacturing.

• Direct experience supporting cell therapy ATMP or biologics

• Proven track record of implementing and validating MES/EBR in GMP environments.

• Strong knowledge of CSV (computer system validation) practices validation deliverables and experience authoring IQ/OQ/PQ protocols and trace matrices.

• Demonstrated capability managing multidisciplinary projects from concept through sustained operation including vendor management and budget ownership.

• Strong written and verbal communication skills for technical documentation SOPs validation documentation and audit responses.

Preferred:

• Manufacturing CART experience strongly preferred.

• Experience integrating MES with LIMS ERP (e.g. SAP) WMS and clinical systems; understanding of lab QC workflows and sample management.

• Werum PAS-X experience is preferred.

Other:

• May require up to 10% domestic and/or international travel.

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 please contact us via or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Business Alignment Business Architecture Business Process Design Business Savvy Computer Programming Cross-Functional Collaboration Developing Others Human-Computer Interaction (HCI) Inclusive Leadership Leadership Motivating People Platform as a Service (PaaS) Product Knowledge Software Development Management Strategic Change Tactical Planning Team Management Technical Credibility

The anticipated base pay range for this position is :

$122000.00 - $212750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companys long-term incentive program.
Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:
Vacation 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
Holiday pay including Floating Holidays 13 days per calendar year
Work Personal and Family Time - up to 40 hours per calendar year
Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 80 hours in a 52-week rolling period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year
For additional general information on Company benefits please go to: - Experience:

Senior Manager