We are looking for a process engineer who will work on Continued Process Verification and who will be part of new material introduction project team e.g introduction of new filters, tubing, containers etc. Technical Operations is responsible to execute the polymeric risk assessment for new incoming materials and supplies based on vendor availability. Materials and supplies being used in manufacturing process will be updated and replaced based on vendor availability, therefore
This role will have 2 main responsibilities:
1. Continued process verification within monoclonal antibodies manufacturing so looking for a statistical background (exp in MINITAB is a pré) and being able to review/assess that internal/external factors remain constant and within proper range within the process (e.g. temperature).
2. Participation in a project for new material introduction (e.g. tubing, filters, raw materials in media) in order to produce antibodies. At the moment, the current vendor has low supply so the team are liaising with other potential vendors to see if their products meet regulations.
• Bachelor or Master in Science (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, Engineering)
• Minimal 3 years relevant experience in the (bio-) pharmaceutical industry;
• Proven experience with GMP and compliance
• Proven statistical knowledge and experience
• Analytically strong, precise, and structured work approach
• Collaborator; easy in making connections between people. Like to find her/his way in a virtual organization
• Eager to learn something new
• Flexible and agile in fast responding to change in requests
• Good communicative skills in English language (writing and verbal), Dutch is a plus
Ideally looking for someone who has worked in biologics manufacturing. This will be a remote role initially, so attitude and a pro-active approach is important, the person needs to be assertive and comfortable to reach out to colleagues remotely, they need to be confident in asking questions and decision making. Skills required are knowledge of process technology and analytical skills, GMP and compliance.
First a temporary contract. Salary based on experience, 25 holidays + 11, min. 32 hours per week, 40 hours preferred. Job is onsite in Leiden, but remote work can be aligned from time to time.
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies.
This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!
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. We accomplish this through our broad technical competency, global reach and local execution power. A job within the TO team is very dynamic and diverse.
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.