Manufacturing Engineer II
About the company
Our client is a biopharmaceutical company that is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. Based on your ambition and performance this role provides you a great opportunity to grow your career within this company.
You will work closely with a process development teams to assure process reliability and robustness in preparation for comparability and process validation.
Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation.
Support investigation identify root cause for critical deviations to maintain routine manufacturing operations and determine CAPA for manufacturing
Participate in laboratory experiments that support process development for extended process characterization, investigation resolution, and process improvements.
• Bachelors Degree
• Pharmaceutical Experience - 3+ years strongly preferred
• CAPA / RCA experience
• Experience working in Quality Systems
• Technology transfer experience strongly preferred
• Cell Therapy experience would be a plus