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Cell Culturing Manufacturing Operator
4 months ago
**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 manufacturing-support 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 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 as well as the 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 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 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.
- 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 non-routine 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 _**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, manufacturing-support, and lab equipment.
- Knowledge of Process Ex
