J&J Family of Companies Sr Manufacturing Operator in Leiden, Netherlands

Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To build up and strengthen our Operations Team in the Launch Facility we are looking for several enthusiastic and talented

Sr Manufacturing Operators

(USP + DSP)

Department:

The Launch Facility is a state of the art vaccines manufacturing facility which is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes. Currently the facility is in a start-up phase before commercial batches can be produced.

The manufacturing systems are in the end phase of commissioning and qualification phase. Water batches and engineering runs are scheduled for execution. The Operations Team plays a key role in this start up process and delivery of the first vaccine engineering batches by mid-2018.

Additionally, all corresponding production documentation, training records, logistic systems, inventory and all kinds of related activities to make the launch facility ready should be set-up. The final phase is that this Operations Team can execute the vaccine manufacturing process according all EHSS and cGMP regulations.

Job Description:

As Sr. manufacturing operator, you will perform the water batches and engineering runs in the new facility, detects abnormalities and participate in problem solving and implementation of corrective actions. In parallel with these process and manufacturing activities you will be assisting in writing production documentation and training records. And last but not least you will be responsible as area owner for support activities, such as tracking documentation and computer systems, "basic asset care", ensure the cleanliness (5S), maintenance of the area and equipment, sampling, transfer of knowledge etc. to ensure the new launch facility is ready to produce within EHSS and cGMP regulations.

As Sr. manufacturing operator, you work closely with the process engineers and manufacturing specialist within the launch facility.

As Sr. Manufacturing Operator, you will be responsible for:

  • Taking part in all activities related to the production of cGMP batches in the launch facility. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.

  • Accurately completion of documentation such as batch records, logbooks, etc.

  • Working precisely, detecting and solving acute problems and communicate possible abnormalities.

  • Preparing, assemble and disassembly of process equipment for production activities.

  • Actively participating in setting up documentation to ensure successful production runs.

  • Responsible as area owner that the production areas are according EHSS and compliance standards.

  • Internal organization of the launch facility, including ISL, 5S and kanban systems.

  • Involvement in deviation investigation and follow up.

  • Write training documentation and perform training of new operators.

  • Supporting process excellence activities to continuously improve the work as well as personal skills.

Kwalificaties

Qualifications:

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

  • 4-6 years’ experience in a biotechnology or biopharmaceutical industry environment.

  • Expert in cell culture (USP), virus propagation and / or downstream processing (DSP).

  • Experience with cGMP environment and EHSS standards is required.

  • Certified Lean Yellow Belt, preferably Green Belt.

Competences:

  • 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 Dutch and English, both verbally and in writing.

  • Able to work in 16/7 when launch facility is in commercial production.

Primaire locatie

Nederland-Zuid Holland-Leiden

Organisatie

Janssen Biologics (7266)

Functie

Production

Requisition ID

1700201101W