Operations Process Trainer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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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 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.

Key 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.

Qualifications / Requirements:

• A minimum of a Bachelors 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.

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 please contact us via or contact AskGS to be directed to your accommodation resource.

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