Sr. Manufacturing Operator - Pollux

Senior Manufacturing Operators (USP) Would you like to be directly involved in supporting a new process that can changes 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 160.000 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 Senior 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. Monitoring progress and checking whether the activities (within an assigned part of the department) are being carried out correctly: Is the point of contact for production-related questions within the team. Signals deviations (gaps), resolves them correctly and preventively. Takes the initiative to solve problems, where possible yourself and otherwise in close cooperation with the Manufacturing Supervisor and/or manufacturing specialist/process engineer. Replaces the Manufacturing Supervisor in the absence of process related tasks. Responsible for preparing the training schedule and ensuring that appropriate training is given to manufacturing operators in existing and new processes and technologies. Responsible for continuous improvement of work processes and procedures. Signals structural shortcomings and opportunities for improvement. He/she coordinates improvement initiatives (CI) that are practical in nature and do not require support from other departments. Is involved in larger or more complex initiatives. Is responsible for (co-)developing work processes and procedures in consultation with manufacturing specialist/process engineer. Proactive role in department improvement initiatives (BI/CI improvements). Participates in the initiation phase of QIs and is involved in deviation investigation and follow up. Qualifications (Minimum) qualifications: Minimum education: relevant education on MBO level 4. Preferred is a degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education). Experience of 2 - 6 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. A certified Lean Yellow or Green Belt is preferred. Knowledge of used management systems (I.e., Trackwise QEM, SAP, eLIMS) 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 More information: Start date: ASAP Period: Permanent position Band: 23 Primary Location Netherlands-South Holland-Leiden- Organization Janssen Biologics (7266) Job Function Operations Requisition ID 00001IKN