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Originele vacaturetekst

Manufacturing Specialist VLF (Yacht Life Sciences)

Yacht Life Sciences has a vacancy for a Manufacturing Specialist at the Vaccine Launch Facility (VLF) of Janssen Biologics B.V. in Leiden.


This role is particularly focusing on the trouble shooting and optimization of the existing fill installation and the start up of a new automated fill installation for their COVID-19 vaccine production.


As Manufacturing Specialist, you will be responsible for the assigned equipment to be available and robust to meet the VLF production schedule. This includes direct support and leading the root cause analysis for operations whenever there is an issue, as well as improving the documentation, training and procedures related to the equipment. You will work closely with the manufacturing operators, GMP specialists, Maintenance department, Quality department, and process engineers.


 As Manufacturing Specialist, you will be responsible for: 

  • Acute troubleshoot & support production of cGMP batches in the VLF. This includes processes such as cell and virus culture, purification processes, formulation & fill and in-process testing.
  • Taking the lead in root cause investigations of complex deviations and for the implementation of preventive actions. 
  • Initiating and handling of compliance records (change control, events, CAPA, deviations).
  • Initiate, and execution of test protocols that help to improve the system or process.
  • Working precisely, detecting and solving acute problems and communicate possible abnormalities.
  • As equipment owner, that the production equipment is in validated state, documentation is up to date, well maintained, and capacity meets planning.
  • As equipment owner, the process equipment related reports and KPI’s. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity.) 
  • Leading process excellence activities to continuously improve the work as well as personal skills.
Uren:
40
Type vacature:
Intern

Over de werkgever

The Vaccine Launch Facility (VLF) is a state-of-the-art vaccines GMP manufacturing facility located at the Bioscience park in Leiden, where Janssen Biologics produces vaccines against infectious diseases, such as Covid19, HIV and 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 pandemic the VLF is one of the production sites for Janssen’s lead vaccine candidate for COVID-19. 
 
Department:
The Centre of Expertise (CoE) plays a central role within the VLF, divided in two expertise: 1) Single use technology and 2) Manufacturing systems specialism for USP and DSP. The CoE is responsible for batch continuation by troubleshoot & support in production, robust and availability of process equipment. The CoE is key in clear translation of strategic and tactic projects to a workable process and environment for the shop floor. They always work against the high-quality standards and safety and compliance regulations that are applicable for vaccine manufacturing. CoE is responsible to support the production teams with specialized and in-depth knowledge and skills on their production processes. The Centre of Expertise (COE) is a team of around 15 people.

Wat wij bieden

We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is anticipated). Full time, salary between 4000 and 5000 euro gross per 4 week period.

We will offer a competitive benefit package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth. 

Vaardigheden

  • Bachelor or Master degree in biotechnology, biochemistry, biomedicine, process technology or similar
  • > 4 years similar work experience in a biotechnology or biopharmaceutical industry environment
  • Working knowledge of Fill processes and installations of biopharma products (10 liter scale, no vials).
  • Working knowledge with automated fill installations and in particular the start-up of such installations
  • Working knowledge with the application of single use technology in fill installations
  • Experience with cGMP environment and EHSS standards
  • Certified Lean Yellow Belt, preferably Green Belt
  • Good communication in English (Dutch will be a plus)

Opleiding

hbo

Wat wij bieden

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