The Role of a Lifetime: QA CSV Engineer - CAR-T Hub
The Johnson & Johnson Innovative Medicine team is on a mission to change the trajectory of health for humanity. As a QA CSV engineer, you'll play a critical role in bringing life-saving therapies to patients. You'll work in the Advanced Therapy Quality team, which is responsible for ensuring the quality of computerized systems used in CAR-T therapy.
CAR-T therapy works by harnessing the power of a patient's own immune system. The patients' own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen. To achieve this, we need professionals who can ensure the quality of computer systems used in CAR-T therapy.
Your key responsibilities will include providing quality oversight for computer system validation activities, reviewing and approving CSV documents, and acting as Process Owner for Computer Systems Validation management. You'll also need to maintain knowledge of international laws, guidelines, and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking, and literature studies.
As a QA CSV engineer, you'll have the opportunity to make a real difference in people's lives. You'll work with a talented team of professionals who share your passion for quality and innovation. If you're passionate about quality and eager to take on new challenges, this could be the role of a lifetime for you!
What We Offer:
We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package. Our benefits include medical, dental, and vision insurance, 401(k) matching, and paid time off. Additionally, we offer flexible work arrangements, including telecommuting options, to help you balance your work and personal life.