Janssen Biologics 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 Vaccines Launch Facility we are looking for several enthusiastic and talented
Senior Manufacturing Operators VLF
(USP + DSP)
Would you like to be directly involved in the fight against the global
"Corona virus" (COVID-19) pandemic? Then keep reading!
The Vaccines Launch Facility:
The Vaccine Launch Facility (VLF) is a state-of-the-art vaccines GMP manufacturing facility located at the Bioscience park in Leiden, where we produce vaccines against infectious diseases, such as HIV RSV. The VLF is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes. As a response to the global COVID-19 pandamic the VLF has been appointed as one of the production sites for Janssen’s lead vaccine candidate for COVID-19.
The operations department plays a central role within the VLF and is responsible for on time manufacturing and delivery of the planned batches against the high-quality standards and safety and compliance regulations that are applicable for vaccine manufacturing.
The operations department holds around 60 people and is divided in 4 teams. 3 Teams are responsible for the actual on time production and delivery of the batches (USP, DSP and Operations Support) and one Team (COE) is responsible to support the production teams with specialized and in-depth knowledge and skillson our production processes..
To enable the upcoming production expansion for the COVID-19 vaccine in the VLF we are currently recruiting for manufacturing operators to strengthen and expand our current operations team.
As Sr. manufacturing operator, you will perform the upstream and downstreamprocesses in the facility, detects abnormalities and participate in problem solving and implementation of corrective actions. 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 VLF.
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.
Perform training of new operators.
Supporting process excellence activities to continuously improve the work as well as personal skills.
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.
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 shifts (16/5 or maybe 24/7)when launch facility is in commercial production.
Netherlands-South Holland-Leiden- Organization
Janssen Biologics (7266) Job Function
Operations Requisition ID
Open Positions from Johnson & Johnson Family of Companies