Yacht Life Sciences has a vacancy for a Senior Operator to help Janssen Vaccines with the upcoming COVID-19 vaccine manufacturing campaign.
As a Senior Operator you are primarily responsible for the cGMP production of CTM material, as requested by the organisation. Apart from production operations you will be updating documentation, be responsible for predefined process steps, and the state of related equipment. Next to these core tasks, small improvements and innovative projects will be a stable part of your daily work package. You will also be tasked to do data management, acute problem solving, and many other small and diverse tasks. As the job entails team work within a diverse and global organisation, we require good communications skills in English.
The department DSO is an international team of about 40 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA and warehouse. Their passion is to deliver high-quality results to our customers and to seek for opportunities for improvement: never a dull moment!
Within the department four teams operate, each with specific responsibilities: Preparations, Cell culture, Downstream processing and the Operations Support Team. The teams are responsible for their cGMP status by maintaining the documentation system, reporting quality issues and performing the resulting corrective actions, master batch documentation, training and inspection readiness.
- HBO/BSc with >3 years of proven experience in pharmaceutical/biotechnology
- Expert in cell culture (USP), virus propagation and / or downstream processing (DSP)
- Experience with change controls, non-conformances and CAPA records
- Experience with cGMP and EHSS standards is required
- Lean green belt certification is preferred
- You have quality always as main goal, efficiency second aims for full customer satisfaction. What is asked you deliver with the required quality within the agreed time-frame.
- You have a high degree of accuracy, initiative, and independence
- You are flexible and stress-resistant and remain positive when priorities change
- You help team members by giving advice and sharing feedback on technical and personal level
- You have great social and trainer skills, are able to provide and receive feedback in a constructive way. You make yourself part of discussions and help transform these into positive actions.
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). Salary between 2800 and 3600 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.
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV and Ebola. This is also the place where we will be producing the COVID-19 vaccine material.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.