Operations Process Trainer

Johnson & Johnson Innovative Medicine • Raritan, NJ

1d • 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. 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 An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. We are searching for the best talent for a Operations Process Trainer based in Raritan, NJ. The Operations Process Trainer will be responsible for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will work within an Operations Unit and collaborate closely with Operations Associates and Management to facilitate readiness of trainees and effective process qualifications. The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust training, regulatory compliance, team readiness, and processing of product prior to release to patients.

Requirements

• A minimum of a Bachelor’s Degree in a Life Sciences field or equivalent technical discipline/experience is required.
• A minimum of 4 years relevant work experience is required.
• Candidate must have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Experience with training methodology, adult learning theory, instructional design and Train-the-Trainer programs.
• Curriculum and module design experience.
• Advanced computer skills and practical knowledge of MS Office Suite, SharePoint, and other related systems.
• Good verbal and written communication skills.
• Excellent organizational skills.
• Ability to effectively prioritize and execute tasks in a fast-paced environment.
• Works well in a team-oriented, collaborative environment.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Proactive and continuous improvement oriented.
• Ability to lead with influence.
• cGMP manufacturing.
• Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Strong analytical, problem solving and critical thinking skills.
• Project management.
• Change management.
• Transparent, Passionate, Fearless and Accountable.

Responsibilities

• Leads, coaches and delivers 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
• 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.

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level