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 Operator VLF
(USP + DSP- dayshift )
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 Facility is a state-of-the-art vaccines GMP manufacturing facility at the Bioscience park in Leiden, where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV and RSV. This is also the place where we produce the COVID-19 vaccine that was developed in-house by Janssen Vaccines and Prevention. The vaccine facility is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes.
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 100 people in 2021 and is divided in 4 teams. 3 Teams are responsible for the actual on time production and delivery of the batches (UpStream Processing, DownStream Processing and Operations Support) and 1 Team (COE) is responsible to support the production teams with specialized and in-depth knowledge and skillson our production processes.
Operation USP is responsible for the cell grow and virus production activities at the VLF. DSP is responsible for the purification and bulk filling of the produced virus material.
USP/DSP will consist of 3 sub teams, with each 10-15 operators, working in shifts. Additional we want to strengthen our USP and DSP shifts with senior operators in the day shift. This position will be for 1 year to strengthen our shiftteams during the Covid 19 start-up period and use this year to train our current operators to the next level.
As day shift Senior Operator, you have the same responsibility’s as the shift Sr operators and will closely worked together. The dayshift Senior Operator will be an experienced senior who will train the other (Sr) operator in all kind of operations additional tasks. You will also take responsibility for tasks that continued during the Monday-Friday work week.
The Sr manufacturing operator is responsible for the upstream and/or downstream processes 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 Senior Operator, you work closely with the process engineers and manufacturing specialist within the VLF.
As Senior 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 (sr) 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.
Experienced as Senior manufacturing operator in VLF USP or 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, Certified train the trainer and TWI experienced
Good communication in Dutch and English, both verbally and in writing.
Netherlands-South Holland-Leiden- Organization
Janssen Biologics (7266) Job Function
Operations Requisition ID
Open Positions from Johnson & Johnson Family of Companies