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.

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Gowning Trainer, Operations to join our team in Raritan, NJ.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc. have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor CAR-T cell therapy. This innovative partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients’ lives by supporting reliable delivery of high-quality Innovative Medicine products? Apply today for this exciting opportunity to be part of the CAR-T team.

The Raritan CAR-T facility manufactures CARVYKTI™, a personalized autologous cell therapy product, in collaboration with our partner Legend Biotech. CAR-T manufacturing requires precise execution across multiple processing steps, quality control procedures, and cleanroom practices to support product quality, patient safety, and reliable supply.

The Gowning Trainer, CAR-T Operations supports the Raritan CAR-T gowning training program within a cGMP-regulated cleanroom manufacturing environment. This role delivers instructor-led gowning training, qualification, and requalification activities for clinical and commercial manufacturing personnel while ensuring training practices remain aligned with company procedures, quality systems, Good Documentation Practices, and applicable regulatory expectations. The Operations Gowning Trainer partners with Manufacturing, Quality, Operations Training, and other stakeholders to maintain reliable gowning capability, support inspection readiness, and drive continuous improvement of aseptic gowning behaviors that protect product quality, patient safety, and operational performance.

KEY RESPONSIBILITIES

• Conduct instructor-led gowning training, qualification, and requalification activities for Raritan CAR-T personnel in support of clinical and commercial operations.

• Support the gowning training program in a controlled cGMP cleanroom environment while maintaining alignment with approved procedures, quality systems, and Learning Management System requirements.

• Coach and assess personnel on aseptic gowning technique, cleanroom behavior, and procedural execution to promote consistent performance and contamination control awareness.

• Accurately complete training records, qualification documentation, logbooks, and other GMP documentation in a clear, concise manner consistent with Good Documentation Practices.

• Partner with Manufacturing, Quality, Operations Training, and cross-functional stakeholders to resolve training issues, support schedule adherence, and maintain readiness for production needs.

• Identify recurring gowning performance trends, training gaps, and emerging risks; escalate observations and support sustainable corrective actions or program improvements.

• Support investigations, audit preparation, and inspection readiness activities related to gowning training, qualification execution, documentation, and cleanroom behaviors.

• Aid in development and continuous improvement of gowning training materials, qualification criteria, job aids, and supporting documentation.

• Maintain a working knowledge of cGMP expectations, aseptic processing principles, contamination control practices, and site procedures relevant to cleanroom entry and gowning qualification.

• Promote a safe, clean, compliant, and team-oriented work environment while performing other duties as assigned to support business and production needs.

QUALIFICATIONS

Education

• Minimum of an Associate’s Degree, Vocational, Certificate, Technical, and/or equivalent degree required.

• A Bachelor’s degree in Life Sciences, Engineering, Education, Training, or a related technical discipline is preferred.

EXPERIENCE AND SKILLS

Required

• A minimum 2 years of relevant work experience.

• Experience working in a cGMP-regulated pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy environment.

• Knowledge of aseptic gowning, cleanroom behaviors, contamination control principles, GMP requirements, Good Documentation Practices (GDP), and training execution expectations.

• Ability to execute instructor-led training, qualification, and requalification activities using approved procedures, curricula, and training materials.

• Strong communication, coaching, observation, and documentation skills, with the ability to provide clear feedback to trainees and appropriately escalate concerns.

• Demonstrated ability to collaborate effectively with Manufacturing, Quality, Operations Training, and cross-functional partners in a fast-paced production environment.

• Ability to interpret written procedures, training requirements, schedules, diagrams, and verbal instructions, and apply them consistently during training execution.

• Must be able to travel between site locations as required to perform the essential functions and responsibilities of the role.

Preferred

• Experience in operational excellence, audit support, inspection readiness, or continuous improvement initiatives.

• Experience supporting training program implementation, qualification strategies, or procedural updates in a GMP-regulated environment.

Other

• This position is assigned to the second shift (2:30 p.m. to 11:00 p.m.), Monday through Friday. Flexibility to work alternate shifts based on business needs is required.

• Ability to wear appropriate personal protective equipment (PPE), follow gowning procedures, and work in manufacturing and cleanroom environments is required. The role also requires standing and walking for extended periods; bending, stooping, and reaching; and lifting up to 25 pounds.

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

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

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility

 

 

The anticipated base pay range for this position is :

$65,000.00 - $104,650.00

Additional Description for Pay Transparency:

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