Manufacturing Operator

Are you ready to be part of something groundbreaking? Do you want to make a real impact on patient lives? Are you passionate about innovation and teamwork?

If the answer to these questions is yes, we are looking for you

Janssen Biologics is recruiting a Manufacturing Operator (USP/DSP/F &F) to join our Operational Readiness team. You will play a crucial role in supporting this new facility now and in the future.

Shift Operations organization:
In full operation, Shift Operations manufactures the Lenti Viral Vector for our customers. This process is following different steps from cell expansion, virus production and purification to automated filling and labelling. The process is performed under strict GMP and BSL2 conditions. During the project the team is preparing the plant for operations and supporting the technology transfer from R&D by developing procedures and training, and the team will produce test and qualification batches.

What you will be doing:
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 an 8/7 shift roster.
- Culturing and inoculation of cells in Shaker Flask and Wave bag (e.g., cell count, dilution, sampling)
- Daily monitoring of Cell culture including in process testing (e.g., cell count, pH)
- Preparing transfection mix (process additions) and transfection
- Preparing of Benzonase solutions (process additions)
- Harvesting SUB and Clarification of harvest
- Sample handling for both UPS department

Downstream Processing department (DSP)

DSP is responsible for the purification using various techniques. During the project phase you will work normal weekdays. The DSP team will consist of 10 operators, with a roster of dayshift.
- The core task of the DSP is the purification using various techniques, including:

- Ion Exchange chromatography
- Sterile filtration, including PUPSIT filter integrity testing
- Ultrafiltration and diafiltration
- Sample handling for the DSP department

Fill and Finish department (F&F)

F&F is responsible for the final filling and preparing the product for freezing and storage. During the project phase you will work normal weekdays. However, during start-up operation F&F consists of 3 sub teams, with each 4 operators. The shift roster will be primarily dayshift, with 2 late shifts once every three weeks.

The core task of Fill & Finish is the final Filling using various techniques, including:

- Preparation of Isolator and filler
- Filling of product in a grade A isolator
- Aseptic working in an isolator working with automated filling robot
- Visual examination of product vials
- Labelling of vials, and storage of the product in the DS freezers
- Support the installation and operation of new equipment, writing job breakdown sheets for training and work instructions.
- Cooperating in the execution of the daily task and the supporting activities of the department according to a detailed schedule.
- Perform process and documentation activities” escalate process deviations, notice process gaps, and solve them, train operators.
- Continuous improvement of work process and procedures.

**Qualifications**:
We would love to hear from you, if you have the following esential requirements:

- Preferably an MBO or HBO in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
- 1-3 years’ experience in a biotechnology or biopharmaceutical industry environment as a manufacturing operator, or willing to learn on the job.
- Preferred experience of 1 year in a BSL2 environment, with expertise in cell culture and virus propagation (USP) or purification (DSP) or Fill & Finish (F&F), GMP and EHS standards.
- Proficient communication skills in English, both verbal and in written (preferably also in Dutch).
- Analytical ability and dealing with complexity.
- High degree of accuracy, initiative, and independence.
- Flexible, can deal with changing priorities, and stress resistant. - “Can do” attitude, critical and proactive.- Able to work in shifts.

This is what awaits YOU at J&J:

- Be part of a global market leader.
- Experience a dynamic and inspiring work environment.
- Opportunities for career growth and continuous personal and professional development in areas of technology and leadership.
- Personal Development Plan - such as access to further education & training, mentoring and coaching, development opportunities on-the-job or through exciting projects.
- Connect with a strong global network of talent and expertise, with opportunities to learn and move across cultures and work environments.
- Competitive benefits package including 36 holidays, a bike plan, gym allowance, all kinds of mental support for you and your family, additional insurances and solid pension arrangements, referral awards, jubilee gifts and more
- Equal opportunity employer.

What type of mark will you make?

Diversity, Equity & Inclusion at J