About the Company:
Our client are at the forefront of immunotherapy and engineered T cell therapy. They are helping change the paradigm of cancer treatment and they are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where they make discoveries every day – discoveries that include their own capabilities and their individual potential.

About the Role:
As a Process Engineer for Manufacturing Science and Technology (MSAT) you will provide process and product expertise for GMP manufacturing, technology transfers, process validations for products.
Additionally, you will write product impact assessments for deviations and change controls, technical reports, and provide technical assessments.

Key responsibilities:
– Perform process support as process development representative for manufacturing site.
– Support cross functional teams to perform root-cause investigations and deviation resolution for moderately complex problems
– Collaborating with technical and operational stakeholders, write and review SOPs, batch records, and other operational related documents as needed
– Lead continuous improvement projects and support initiatives.
– Support regulatory inspections and projects for regulatory commitments
– Support technology transfers and new product introductions
– Understanding of process development, validation, and Lifecycle management to support comparability studies, process validation, and licensure changes

Requirements:
– Degree in Engineering, Biotechnology, Life Sciences or related discipline.
– At least 3 years of pharmaceutical manufacturing, technology transfer or process development experience.
– Previous experience with cell therapy products is a plus
– Process validation experience is a plus
– Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
– Ability to think critically and demonstrate troubleshooting and problem solving skills
– Excellent interpersonal, verbal and written communication skills

Interested? Do you know anyone who would be interested in this role or do you see yourself in this role then click on APPLY button and know more in details.