Aseptic 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.

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 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 Bachelors 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 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.

• 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 experience

• 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.

Other:

• Ability to work a flexible schedule due to business needed and project timelines

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

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 internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Agile Manufacturing Analytics Dashboards Chemistry Manufacturing and Control (CMC) Communication Data Compilation Data Savvy Execution Focus Gap Analysis Good Manufacturing Practices (GMP) Issue Escalation Operational Excellence Pharmaceutical Industry Plant Operations Proactive Behavior Problem Solving Process Optimization Project Administration Quality Auditing

The anticipated base pay range for this position is :

$63000.00 - $101430.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

Positions Represented by CBA: Please use the following language:

This position is eligible for benefits to include medical dental vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.



The following link to general company benefits information MUST also be included in the posting: Please use the following language:

For additional general information on Company benefits please go to: - position is eligible to participate in the Companys long-term incentive program.



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