Manufacturing Engineer Manager
Location: NetherlandsManufacturing Engineer Manager
Company: International Biopharmaceutical
Location: Amsterdam Area
Starting date: 1 March
Organization
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.
Description
• 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.
Requirements:
• 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
