Manufacturing Engineer

Job description
Do you have a few years of experience from manufacturing in Pharma Industry and GMP and ready to step in as consultant in a very exciting role as Manufacturing Engineer? You will have the opportunity to use your knowledge within pharmaceutical development projects, process development and optimization as well as ensure that products are available for commercial manufacturing.  


Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you will have a large network and many social activities.

Responsibilities
Below are some of your responsibilities that might be in the role as a Manufacturing engineer consultant:


Support process improvements and validation activities
Work with process risk assessments to improve the overall level of process control
 Conduct and coordinate investigations, identifying root cause and implementing CAPA’s
Ensure production documentation is aligned with current practice and regulatory and global guidelines
Author regulatory documents within the CMC area for e.g. NDA submissions
Manage and work closely to vendors to deliver robust, scalable and cost-effective manufacturing processes


Qualifications
To be able to succeed and be happy in the role, below qualifications are mandatory:


MSc or BSc in Chemical Engineering, or other relevant specialization
Solid knowledge in cGMP
A minimum of three years of experience process development, process validation and manufacturing of pharmaceuticals
Experience in authoring regulatory documents
Experience in writing CMC documents for NDA and MAA dossiers
Experience in handling CAPA’s
High proficiency in English

As a person the most useful traits will be that you are communicative, self-motivated and structured. Further that you are ready and curious to learn and adaptable to changes in work assignments. 

About the company
Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!