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  • Location

    Leiden

  • Job title:

    Manufacturing Operation Specialist (Materials Supply)

  • Sector:

  • Job ref:

    47286

  • Start Date:

    2021-02-01

Manufacturing Operations Specialist (Material Supply)
Company: Janssen Biologics
Location:
Leiden Area
Starting date: 1 February (preferred)

Currently we are actively recruiting an Manufacturing Operations Specialist for the Material Supply for a multinational pharmaceutical company that has been for over 25 years a leader in the field of biomedicine.

Department

The Vaccine Launch Facility (VLF) 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 (including COVID-19). The Operations Department plays a central role within the VLF and is responsible for on time 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 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 1 Team (COE) is responsible to support the production teams with specialized and in-depth knowledge and skills on our production processes. Operations Support is a growing team and will exist of approximately 45 people. We are currently recruiting to extend our group with a manufacturing specialist, to provide operations support with specialized and in-depth knowledge and skills on our production, supply and storage processes. From revising work instructions, acting as Single Point of contact, representing the VLF in project teams, initiating change controls and solve Quality Issues and Corrective preventive actions.

 

Description

As manufacturing specialist, you will support the production batches in the VLF. You are the lead in solving acute problems, detecting abnormalities and implementation preventive actions. In parallel with these process and manufacturing activities, you are responsible as Single Point of Contact for the corresponding supplying departments like Distribution Centre, Warehouse, Single Use team and the shift reams. As manufacturing specialist, you work closely with your operations support team and within the other teams of the VLF.

 

As Manufacturing Specialist Operations Support, you will be responsible for:

  • As VLF material supply owner you are responsible for the ordering and stock controlling of single use-items, ready-made buffers, consumption items, buffers and medium and act as single point of contact with the supplying departments.
  • Taking part in activities related to the production support of cGMP batches in the launch facility. This includes processes such as waste disposal, storage of product in the freezer park, shipments, single use supply, fumigation of the VLF and sampling.
  • Acute troubleshooting when problems occurred during production.
  • Taking the lead in root cause investigations of complex deviations and for the implementation of preventive actions.
  • As VLF material supply owner, that the production equipment is in validated state and well maintained, and that there is enough capacity for production to meet the production schedule.
  • As equipment owner, the process equipment related reports and KPI’s. You will have the overview and knowledge of the status of the material supply (e.g. uptime, downtime, emergency orders.) 
  • Initiating and handling of compliance records (Change controls, events, CPA, deviations, reports).
  • Leading process excellence activities to continuously improve the work as well as personal skills.

 

Qualifications:

  • Bachelor’s degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
  • 3-5 years’ experience in a biotechnology or biopharmaceutical industry environment.
  • Experience with cGMP environment and EHSS standards is required.
  • Certified Lean Yellow Belt, preferably Green Belt.
  • In the possession of a network within JBV or Vaccines and good connection skills.

Competences:

  • High degree of accuracy, initiative, and independence.
  • Innovative and exploring person which detect abnormalities.
  • Flexible, can deal with changing priorities and stress-resistant.
  • Enthusiastic team player.
  • “Can do” attitude, critical and proactive.
  • Practical technical understanding and conceptual thinking.
  • Good communication in Dutch and English, both verbally and in writing.

Interested?

If you are interested in this position, please apply or email s.vanderkleij@sire-search.com