Car-t Manufacturing Operator - Raritan, United States - Johnson & Johnson

Johnson & Johnson
Johnson & Johnson
Verified Company
Raritan, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Operator located in Raritan, NJ.

#CART

:

This position is responsible for performing manufacturing procedures and the execution of 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.


ESSENTIAL FUNCTIONS:


  • Be part of the manufacturing operations team responsible for the production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
  • Independently execute manufacturing or manufacturingsupport processes according to standard operating procedures and current curriculum.
  • Execute manufacturing activities common to 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).
  • Work in a teambased, crossfunctional 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 as well as input of team members.
  • Handle humanderived materials in containment areas.
  • Support schedule adjustments to meet production.
  • Accurately complete documentation in SOP's, 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 working 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.
  • Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
ADDITIONAL RESPONSIBILITIES/DUTIES:


  • Support the ongoing production schedule by
:

O Report to work on time and according to the shift schedule.

O Perform other duties as assigned.

O Attend departmental and other scheduled meetings.

O Practice good interpersonal and communication skills.

O Demonstrate a positive team-oriented approach in the daily execution of procedures.

O Promote and work within a team environment.

O 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.
  • This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
AUTONOMY and COMPLEXITY:


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

Qualifications:


NATURE OF TASKS:


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

COMPUTER ABILITY:


  • Basic understanding and working knowledge of systems required per curriculum. Utilizes tools within MS Office and other systems to improve business effectiveness.

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

Bachelor's 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, manufacturingsupport, and lab equipment.
  • Knowledge of Process Excellence Tools
  • Possesses solid knowledge of routine and nonroutine t
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