Aseptic Operations Process Trainer

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:

Business Enablement/Support

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

Learn more and apply to this exciting new role!

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 strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

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

This role will Lead, coach and deliver a holistic, effective process qualification program for Operations trainees who support daily clinical production and strategically prepare for commercial supply of a CAR-T product.

Key Responsibilities:

• Manages, plans, coordinates, prepares and performs hands-on process training curriculum for specific unit operation qualification.

• Prepares and maintains training lab, materials, and equipment.

• Conducts Observation, Side-by-Side, and Process Qualification activities for new trainees.

• Assess technical qualifications of new Operations trainees.

• Conducts knowledge and skill checks for Operations.

• Work with Operations Management to assess and report on new trainee development.

• Work with Operations Management to develop streamlines and robust qualification process.

• Helps write or revise Operations training procedures, practices, and skills assessments.

• Performs training assessments for new and updated procedures.

• Identifies technical training needs and expectations, monitors progress, addresses and resolves gaps in training requirements for Operations.

• Supports evaluation of appropriate compliance courses for Operations.

• Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel.

• Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution.

• Knowledge of LMS system.

• Supports the maintenance and reporting of quality training metrics.

• Support daily manufacturing activities when necessary.

Qualifications

Education:

• A minimum of a Bachelor’s Degree in a Life Sciences field or equivalent technical discipline/experience is required.

Experience and Skills:

Required:

• A minimum 4 years of relevant work experience is required.

• Experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning