Senior Manager, Manufacturing Execution Systems (MES) and Automation Lead

Johnson & Johnson•Raritan, NJ

9d•Onsite

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 https://www.jnj.com 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 https://www.jnj.com/innovative-medicine We 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 CAR‑T 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 on‑time delivery.

Requirements

A minimum of a Bachelor’s degree is required, preferably with a focus in Science or Engineering. Master’s or higher degree is preferred.
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 multi‑disciplinary 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.

Nice To Haves

Manufacturing CAR‑T 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.
May require up to 10% domestic and/or international travel.

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 CAR‑T site, including roadmap, standards, architecture, and governance aligned to manufacturing and quality requirements.
Own end‑to‑end delivery of MES projects: including requirements, design, integration, commissioning, CSV (IQ/OQ/PQ), and lifecycle support.
Implement CAR‑T 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 go‑live support to ensure user adoption and sustained operation of MES capabilities.
Represent the MES function during regulatory inspections and audits.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
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