Manufacturing Engineer Manager
Company: International Biopharmaceutical
Location: Amsterdam Area
Starting date: 1 March
Our client is a biopharmaceutical company 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. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. We are currently seeking a Process Engineer II to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
• Work closely with 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.
• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
• Work with vendors and suppliers to define requirements and understand functional specifications
• Support investigation identify root cause for critical deviations to maintain routine manufacturing operations and determine CAPA for manufacturing.
• Write and review technical documentation (batch records, SOPs, protocols & reports for equipment qualifications, comparability, process and cell therapy manufacturing process validation testing).
• Participate and report to a cross-functional development team to advance production activities.
• Ensure successful manufacturing process comparability and process validation runs
• Participate in laboratory experiments that support process development for extended process characterization, investigation resolution, and process improvements.
• Bachelor’s 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