About the company

It is a biopharmaceutical company engaged in the development of innovative immunotherapies for cancer. The goal is to provide rapid, sustainable long-term response and remove the burden of chronic care. The company focuses on the cells of the immune system that detect disease and viruses (chimeric antigen receptor (TCR) and T cell receptor (TCR)). They seeks to recognize, kill and enhance these cells.
In Europe. They are recruiting talent to support the development of the European region. We are building a state-of-the-art factory in Hoofddorp for this purpose. Currently we are looking for motivated talent for different positions to support our innovative immunotherapy for cancer.

About the role

-  You will  evolve subject Matter Expert for cell therapy process equipment, clean rooms, and clean utilities
-  You will  implement Reliability Engineering focused on the following: Loss Elimination and  Efficiency Improvement, Risk Management, and Asset Life Cycle Management
-  You will  Implement site reliability program. Pull metrics and partner with engineering team for implementation of improvement initiatives.
-  You will plan and implement reliability methods that reduce losses and reduce maintenance and production costs
-  You will responsible for developing and maintaining Asset Life Cycle Management, including equipment records, spare parts lists, maintenance and calibration plans.
-  You will participate in evaluation of new technology and process automation for introduction into GMP manufacturing including optimizing single use components for system closure
-  You will interact with the automation team to develop fully automate the MFG process with integration to Electronic Batch Records
-  You will Assist in design, procurement, C&Q, and PPQ batches to license the facility

Requirements

-MS Degree in Biochemical Engineering or Chemical Engineering or related field and  5+ years’ experience in cGMP commercial manufacturing and regulatory requirements
- Understanding of basic engineering principles, experience as a reliability engineer
- Cell culture or aseptic processing experience
-Previous experience with cell therapy products is a plus
-Demonstrated troubleshooting and problem-solving skills with GMP process equipment