Manufacturing Execution Systems (MES) Project Manager

Johnson & Johnson Innovative Medicine•Raritan, NJ

21h•$102,000 - $177,100•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 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. 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 Manufacturing Execution Systems (MES) Project Manager 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 Manufacturing Execution Systems (MES) Project Manager to support MES delivery, integrations, and validation at the Raritan CAR‑T manufacturing site. This is a hands‑on, project‑focused role ideal for a candidate with 5–7 years of MES/automation experience in regulated pharma/biotech environments. The MES Project Manager will plan and execute MES projects, coordinate vendors and site stakeholders, support CSV activities, and drive successful go‑lives that maintain compliance and enable on‑time patient product delivery.

Requirements

Minimum 6 years of experience working with MES, manufacturing automation, or OT/IT integration in regulated pharma/biotech manufacturing
Practical experience supporting MES implementations, integrations, FAT/SAT, and go‑lives; exposure to CSV and validation deliverables
Familiarity with GMP, 21 CFR Part 11, ALCOA+ data integrity principles, and validation practices
Strong project management skills: able to develop project plans, manage schedules, coordinate cross‑functional teams, and drive tasks to closure
Excellent written and verbal communication skills for requirements documentation, test plans, SOPs, and status reporting
Strong problem solving and troubleshooting skills in MES or control system contexts
Comfortable working onsite and supporting hands‑on activities during commissioning and go‑lives

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

Responsibilities

Manage end‑to‑end MES project activities for site initiatives: requirements gathering, functional specifications, vendor coordination, scheduling, risk mitigation, and delivery to scope and budget.
Coordinate FAT/SAT, commissioning, and go‑live activities with vendors, IT, manufacturing, and quality and validation teams.
Support CSV activities: develop or execute test scripts, assist with IQ/OQ/PQ documentation, maintain trace matrices, and close validation items.
Translate operational and quality requirements into MES user stories/functional requirements and acceptance criteria.
Work hands‑on with system integrators and site engineers to configure, test, and troubleshoot MES integrations with various systems (LIMS/QC, ERP (SAP),PLC).
Create and maintain project plans, status reports, risk logs, and change control documentation; communicate progress and escalation items to business partners.
Support creation and delivery of training materials, SOPs, and go‑live support to ensure effective user adoption.
Participate in root cause investigations for MES incidents and support corrective actions (CAPA) and continuous improvement efforts.
Ensure project and system activities align to GMP, data integrity (ALCOA+), and 21 CFR Part 11 / EMA Annex 11 expectations; escalate compliance concerns to Quality.
Support site MES maintenance and minor enhancements as part of a broader team (triage, ticket resolution, coordination with Senior Manager for prioritization).

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)).
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: - https://www.careers.jnj.com/employee-benefits