Cell Culturing Manufacturing Operator - Raritan, United States - Johnson & Johnson

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

2 weeks ago

Mark Lane

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Mark Lane

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Description

Cell Culturing Manufacturing Operator (multiple openings)

Manufacturing Operator, CAR-T

DESCRIPTION:


Janssen Pharmaceuticals, Inc. , a member of Johnson & Johnson's Family of Companies, is recruiting for a
Manufacturing Operator, CAR-T 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 the 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 the input of team members.
  • Handle humanderived 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 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:

  • 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 teamoriented 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.
  • 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 46 Years of Biotech/Pharmaceutical experience or equivalent industry experience
    _OR _Bachelor's degree required in Life Sciences or Engineering, with 02 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 Ex
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