Your main responsibilities:
- Ensure that the lyophilization processes at the new production site meet the quality requirements.
- Process, evaluate and report the test results.
- Testing various processes at the new production site.
- Gaining product knowledge with the present knowhow of colleagues.
- Writing SOP's and other protocols.
Our client is searching for a (Senior) Process Transfer Engineer, who will be responsible for maximizing product quality in an efficient and timely manner. The focus will be on supporting their parenteral products, experience with optimizing lyophilization processes is a must. You will be working in close collaboration with the manufacturing, Quality, Supply chain and Analytical S&T.
Our client generates over 450 pharmaceutical products of which the top 20-30 products are centrally supported by the Science and Technology organization to maximize their growth by making use of advanced knowledge in science and technology and product expertise in a cross collaborative working model.
Science and Technology is tasked with globally facilitating operational excellence and compliance products, reducing operational costs, guaranteeing reliable supply and customer service in changing conditions, and joining forces with the Development department for innovative improvements.
- MSc or PhD degree in pharmaceutical sciences, chemical engineering or food technology.
- At least 5 years of experience with various aspects of manufacturing in a relevant operational or technical support environment.
- Experience with technology transfer, quality systems, costs of goods assessment, unit operation expertise, connecting material attributes with product performance.
- Experience in developing or optimizing lyophilization processes.
- Understanding of parenteral and aseptic manufacturing principles.
- Understanding of sterilization process & validation, such as dry or moist heat sterilization and sterile filtration.
- Strong expertise in troubleshooting.
- Good reporting skills, both technical reports and regulatory CMC docs.
- Able to communicate at various levels with professionals with different expertise.
- Experience with Lean/Six-Sigma methodologies is highly desirable.
- Green belt level or higher.
- Good command of English and Dutch is highly desirable.
- The position is a temporary placement for one year.
- You will work in multidisciplinary teams of 5-10 people.
- You will travel an average of 1 or 2 times a month between France, Turkey and the Netherlands.
XDES is specialist in recruitment van technisch personeel.