Join Our Mission to Safeguard Humanity!
Vaxcyte is at the forefront of clinical-stage vaccine innovation, dedicated to engineering high-fidelity vaccines that shield humanity from the dire health implications of bacterial diseases. Our commitment goes beyond developing solutions for serious infections such as invasive pneumococcal disease, Group A Strep, and Shigella. We have a clear and well-defined roadmap for success, positioning Vaxcyte to make a lasting impact.
What we accomplish is equally as important as How we achieve it! Our collaborative efforts are grounded in four core values:
*RETHINK CONVENTION: We embrace creative and intellectual diversity to innovate and enhance vaccine delivery.
*AIM HIGH: We strive to achieve our ambitious objective of developing the most complex biologics to protect humanity.
*LEAD WITH HEART: At Vaxcyte, everyone is empowered to lead with kindness, fostering an inclusive environment for collaboration and constructive debate that drives our business goals.
*MODEL EXCELLENCE: Our significant challenges demand a collective commitment to integrity, accountability, equality, and clear communication in our decision-making processes.
The Senior Computer Systems Validation (CSV) Engineer will spearhead validation initiatives for cloud-based GxP systems, ensuring compliance with regulatory, quality, and operational standards throughout the system lifecycle. This role emphasizes traditional Computer System Validation while incorporating risk-based Computer Software Assurance (CSA) principles as needed.
The successful candidate will collaborate closely with IT and Quality teams to validate and sustain GxP systems across their lifecycle. A strong background in validating relational databases, cloud infrastructure, and integrated applications within regulated biotech or pharmaceutical settings is essential.
This is a hands-on role that involves authoring and executing validation documents and protocols for GAMP 5 systems.
This position is hybrid, requiring a minimum of three days on-site at our San Carlos, CA location.