Manufacturing Operations Specialist (Equipment)
Company: International Biopharmaceutical Organization
Location: Leiden Area
Starting date: 1 February (preferred)
Currently we are actively recruiting a Manufacturing Operations Specialist for a multinational pharmaceutical company that has been for over 25 years a leader in the field of biomedicine.
The Vaccine Facility of our organization is a state-of-the-art vaccines GMP manufacturing facility at the Bioscience park in Leiden. At this facility our clients produces groundbreaking medicines against diseases that have a global impact, such as vaccines against RSV. This is also the place where they produced a COVID-19 vaccine. 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 vaccine facility 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 in 2021 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.
Operation Support will consist of 3 sub teams, with each 9 operators, working in shifts (16/7) and a staff department responsible for detailed planning of production support, logistic tasks and continuous improvement of the operation processes in the Vaccine plant.
We are currently recruiting for a Manufacturing Specialist who will work in the staff department of Operations support.
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 equipment owner for the corresponding production equipment, documentation and training. 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:
- 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, sampling etcetera.
- Acute troubleshooting when problems occurred during production.
- Taking the lead in root cause investigations of complex deviations and for the implementation of preventive actions.
- The production documentation of the process equipment and batch records to ensure successful production runs can be produced.
- As equipment 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 equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity.)
- 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.
- 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.
If you are interested in this position, please apply or email email@example.com