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About the company

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.

Responsibilities

 
- You will Provide equipment, system and facility qualification guidance and strategy during project planning and development phases
- You will review technical documentation including protocols & summary reports for IOQ / PQ testing, and validation SOPs
- You will manage contractors performing equipment and system qualifications
-Report status and progress of qualification activities or projects to the Leadership team
- You will perform investigations and implement corrective actions related to CAPAs and deviations

Requirements
- MBO or HBO education in related field
- 5 + years experience in GMP in pharmaceutical experience
- Good knowledge about Validation of process