CAR-T Hub QA CSV Engineer - Quality Assurance Expert
We're seeking a highly skilled QA CSV engineer to join our Advanced Therapy Quality team at the CAR-T hub in Europe. As a QA CSV engineer, you'll play a vital role in ensuring the quality of computerized systems used in CAR-T therapy. Your expertise will be essential in maintaining compliance with regulatory requirements, reviewing and approving CSV documents, and acting as Process Owner for Computer Systems Validation management.
The CAR-T therapy uses a patient's own immune system to eliminate cancer cells. The patients' own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen. To bring this life-saving therapy to patients, we need professionals who can ensure the quality of computer systems used in CAR-T therapy.
Your 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.
We're looking for someone with a master's degree or equivalent experience, 3 years' experience in the pharmaceutical industry, and strong knowledge of cGMP/CSV compliance. You should also have experience with Computerized System Validation and a strong ownership and quality attitude. If you're passionate about quality and eager to take on new challenges, this could be the perfect opportunity for you!
Why Choose Us:
We're a dynamic and innovative company that offers a range of benefits, including medical, dental, and vision insurance, 401(k) matching, and paid time off. Our flexible work arrangements, including telecommuting options, allow you to balance your work and personal life. We're committed to creating a diverse and inclusive work environment where everyone feels valued and supported.