CAR T MOI QCB Operator

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Learn more 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 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 are searching for the best talent for a CAR T MOI QCCB Operator to be in Raritan NJ.

This position is responsible for performing manufacturing procedures and executing scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance with company policies procedures and all applicable regulations. Responsible for fostering site pride and J&J citizenship.

Duties / Responsibilities

• Be part of the manufacturing operations team responsible for MOI/QCCB clinical and commercial preparation of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Independently execute MOI/QCCB or manufacturing-support processes according to standard operating procedures and current curriculum.
• Execute daily manufacturing activities for cell culturing purification aseptic processing and cryopreservation using appropriate techniques.
• Perform process unit operations according to standard operating procedures and batch records and record production data and information in a clear concise format according to Good Documentation Practices (GDP).
• Perform tasks on time consistent with quality systems and cGMP requirements.
• Work in a team-based cross-functional environment to complete production tasks required by shift schedule.
• Aid in the development of manufacturing processes including appropriate documentation.
• Drive continuous improvement of manufacturing operations leveraging own observation and input of team members.
• Handle human-derived materials in containment areas.
• Support schedule adjustments to meet production.
• Accurately complete documentation in SOPs logbooks and other GMP documents.
• Demonstrate training progression through the assigned curriculum.
• Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations
• Wear the appropriate PPE when working in manufacturing and other hazardous environments.
• Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors
• Ensure materials are available for production.

ADDITIONAL RESPONSIBILITIES/DUTIES

• Support the ongoing production schedule by:
• Report to work on time and according to the shift schedule.
• Perform other duties as assigned.
• Attend departmental and other scheduled meetings.
• Practice good interpersonal and communication skills.
• Demonstrate a positive team-oriented approach in the daily execution of procedures.
• Promote and work within a team environment
• Learn new skills procedures and processes as assigned by management and continue to develop professionally.
• Support investigation efforts as required.
• Responsible for audit preparation and participation.
• Available for overtime as needed.

AUTONOMY and COMPLEXITY:

• Needs direction to perform manufacturing daily tasks within functional area.
• Support and contribute to projects.
• Assist in troubleshooting routine manufacturing processes.
• Support and execute non-routine manufacturing activities.

NATURE OF TASKS:

Manufacturing Operator

• Basic technical knowledge within functional units
• Demonstrate a basic understanding of the process to perform the assigned manufacturing tasks properly.

Computer Ability:

• Basic understanding and working knowledge of systems required per curriculum. Utilizes tools within MS Office and other systems to improve business effectiveness.
• Accurate Data Entry skills in relevant manufacturing applications (SAP electronic batch records (EBR) etc.

Qualifications / Requirements:

EDUCATION AND EXPERIENCE:

• HS Diploma required with 4-6 Years of Biotech/Pharmaceutical experience or equivalent industry experience.

OR

• Associate degree required with 2-4 Years of Biotech/Pharmaceutical experience or equivalent industry experience.

OR

• Bachelors degree required in Life Sciences or Engineering with 0-2 years of Biotech/Pharmaceutical experience or equivalent industry experience.

LANGUAGE SKILLS:

• Read and interpret documents such as safety rules operating instructions and logbooks
• Review and provide feedback for SOP and Batch Record Revisions

REASONING ABILITY:

• Interpret a variety of instructions furnished in written oral diagram or schedule form.
• Follow instructions
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

MATHEMATICAL SKILLS:

• Add subtract multiply and divide into all units of measure using whole numbers common fractions and decimals.

OTHER SKILLS ABILITIES OR QUALIFICATIONS:

• Knowledge and ability to operate manufacturing manufacturing-support and lab equipment.
• Knowledge of Process Excellence Tools
• Possesses solid knowledge of routine and non-routine testing and sampling methods techniques and related equipment.

PHYSICAL DEMANDS:

While performing the duties of this job the employee:

• Needs to be mobile and able to independently transport themselves between various sites/locations as dictated by the essential functions and responsibilities of the position.
• Is frequently required to communicate with coworkers.
• While performing the duties of this job the employee is regularly required to stand; walk; climb bend stoop; and reach with hands and arms.
• Ability to lift 25 lbs.
• Needs to perform gowning procedures to work in the manufacturing core.

The Raritan CAR-T Manufacturing organization is committed to working with any applicant or employee to make reasonable accommodations in the job structure in consideration of any known physical challenges or disabilities.

Additional Information:

• The selected candidate will have to be amenable to a day shift schedule - Monday to Friday - 8:00 to 4:30 PM

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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