Are you experienced in the field of operations support within the pharmaceutical industry and do you have experience in project management and/or method transfer? We are looking for a manufacturing specialist to strengthen the team and the company's position in the market.
We are looking for an enthusiastic manufacturing specialist to join the operations departiment. In this department groundbreaking medicines are produce against diseases that have global impact. The vaccine production facility is designed for large scale drug substance manufacturing up to 1000 L for commercial use as well as phase III clinical trails. You will be the department project lead and responsible for providing support to the production batches, both for products manufactured in The Netherlands and elsewhere. You detect deviations, solve problems and ensure preventive measures are implemented. Furthermore, you are responsible for the production equipment, documentation and training.
* Production support of cGMP batches in the manufacturing facility; including waste disposal, product storage, shipments, sampling etc.
* Troubleshooting of acute production problems.
* Leading root cause analysis when complex abnormities are detected and implementation of the correct preventive actions.
* You are responsible for production documentation of the equipment and batch records.
* Seeing to it the equipment is validated and well maintained. Ensuring there is enough capacity to meet the production demand.
* Keeping overview of the status of equipment lifecycle, uptime etc.
* Handling compliance records such as deviation reports and change controls.
* Master/Bachelor degree in biotechnology, biomedicine, process technology, or comparable
* A minimum of 3 years of experience in a pharmaceutical setting (working under GMP)
* Preferably production / manufacturing experience
* Experience with cGMP, EHSS standards.
* Certified Lean Yellow Belt or preferably Green Belt.
* Accurate, flexible, stress-resistant, proactive and independent.
* Excellent communication skills in Dutch and English is required.
* Valid Dutch working permit required. Preferably living in the Leiden area.
* Contract: 1 year via Oxford, realistic long- term perspective
* Salary: €2700- €4000 gross monthly based on a full-time position
* Holidays: 25
* Working hours: full-time, day shift.
* Region: Leiden
Vacancy number: 16777