Manufacturing Operator

Manufacturing Operators

(USP/DSP)
Would you like to be directly involved in supporting a new process that can change people's life? Then keep reading

The Lenti Viral Vector Facility:

Janssen Biologics B.V., part of Johnson & Johnson, is setting up a new production facility in Sassenheim.

This new facility will produce lentiviral vector, which is used in the treatment for multiple myeloma, a disease affecting patients globally.

The project team is preparing to get ready for commercial production in 2024.

The coming years will be exciting, with construction and production milestones to be reached, and - equally important - a high performing team to be set up Therefore, lots of interesting Operational challenges lay ahead, mainly in the area of Upstream, Downstream and Fill/Finish.

Are you energized to support a new organization within a global company? Do you want to contribute to improve the life of patients? Do you have a strong passion for people? Then this is your job

Job Description (with the LVV facility in operations):

Department Up Stream Processing (USP) The core task of the USP department is the culturing of cells and infecting those with a virus.

The team is most likely working in a 8/7 shift roster

• Storage and control of cell banks
• Thawing of cells
• Culturing and inoculation of cells in Shaker Flask and Wave bag (e.g. cell count, dilution, sampling)
• Installing and preparation of SUBs
• Inoculation of SUB,
• Daily monitoring of SUBs including in process testing (e.g. cell count, pH)
• Preparing transfection mix (process additions) and transfection
• Harvesting SUB
• Sample handling for both UPS department

Downstream Processing department (DSP) is responsible for the purification and filling using various techniques. During the project phase you will work normal weekdays. However, in full operation DSP consists of 3 sub teams, with each 8-10 operators, working in shifts. The shift roster is most likely 16/7

The core task of the DSP is the purification and filling using various techniques, including:

• Clarification of harvest

- chromatography

• Ultrafiltration and filtration
• Preparation of Benzonase solutions (process additions)
• Sample handling for both DSP department

Filling

• Preparation of Isolator and filler
• Filling of product in a grade A isolator
• Aseptic working in a isolator working with highly automated filling robot
• Reconciliation of batch

Visual examination

• Visual examination of product vials
• Labeling vials
• Reconciliation of batch

Essential job descriptions and responsibilities
The core tasks of a Manufacturing Operator consist of:

• During the project phase you will support the installation and operation of new equipment, writing Job breakdown sheets for training, Work Instructions etc.
• As soon as the facility is in operation you will cooperating in the execution of the daily tasks and the supporting activities of the department. These core tasks are performed according to a detailed schedule. (ISL, 5S and Kanban systems)

Perform process and documentation activities:

• Escalate process deviations to Sr. manufacturing operator
• Manufacturing operator notice process gaps and being part of the process to solve the gaps.
• Train manufacturing operators in existing and new processes and technologies.
• Being part of continuous improvement for the work processes and procedures.
• Active role in department improvement initiatives (BI/CI improvements).

Qualifications:

Qualifications:

(Minimum) qualifications:

• Associates (MBO) degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).

2. 2-4 years' experience in a biotechnology or biopharmaceutical industry environment (manufacturing operator)

• Experience of 1 years in a BSL2 environment, with expertise in cell culture and virus propagation (USP) or purification (DSP), GMP and EHS standards.
• Good communication in English, both verbally and in writing.

Competences:

• Analytical ability and dealing with complexity
• High degree of accuracy, initiative, and independence.
• Flexible, can deal with changing priorities, and stress resistant.
• Enthusiastic Team player.

- "Can do" attitude, critical and proactive.

• Trainer skills, preferably train the trainer certified and TWI experienced
• Good communication in English, both verbally and in writing (preferably also in Dutch)
• Able to work in shifts
• Innovative: Continuous innovation of the work processes and working environment.
• Shows respect and listens to others
• Lives up to our Credo value and serves as an example to colleagues

About Johnson & Johnson

---