Janssen Biologics in the Netherlands is an innovative pharmaceutical company with more than 2000 employees, who work diligently every day on everything that comes with making medicines: from research to disease prevention and from the development of new medicines to the production of medicines.
Yacht Life Sciences has a vacancy for a Validation Engineer to work for Janssen Biologics in Leiden.
Leiden site Technical Operations (TO) is part of the global Technical Operations organization. TO is responsible for validation and standardization of processes and equipment within the Janssen Biologics site and manages Life Cycle Management (LCM) projects and improvement projects. They accomplish this through their broad technical competency, global reach and local execution power. A job within the TO team is very dynamic and diverse. For the Validation Engineer position, we are looking for someone who likes challenges, is collaborative and is keen on working within local as well as global project teams. In support of new product introductions and capacity expansion projects in support of these new products, we are looking for a candidate with strong knowledge and experience in validation and compliance. A self-starter, who would like to take initiative and can define new strategies for implementation of new equipment and products.
The Validation Engineer is primary responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines. The studies must meet the quality requirements. This function encompasses cleaning, mixing and sterilization validation of production equipment.
You are responsible to maintain and continue to improve the validation process. This includes defining and developing new validation strategies for the implementation of new equipment and NPIs.
You are responsible for preparation of protocols, execution of the studies and reporting the results.
You will train and coach engineers in GMP compliance and perform the internal review of protocols and reports.
Assessment of change controls and preparing of validation assessments.
Lead and Support in deviation investigations.
Bachelor or Master in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Engineering)
> 3 years of relevant experience in the (bio-) pharmaceutical industry
Proven experience with GMP and compliance
Expertise in process excellence and/or project management is a plus
Good communicative skills in English language (writing and verbal)
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 possible).
We will offer a competitive benefits package in line with the seniority of the position (salary between 3800 and 4800 euro gross per 4 week period). 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 become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.