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Senior Computer Systems Validation Engineer

VaxcyteSan Carlos, California, United States
Hybrid Full-time $164K/yr - $190K/yr

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Experience Level

Senior

Qualifications

Essential Functions:Lead comprehensive lifecycle Computer System Validation activities for cloud-based GxP systems, including databases and applications.

About the job

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.

Summary:

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.

About Vaxcyte

Vaxcyte is dedicated to revolutionizing vaccine development to combat bacterial diseases. We focus on innovation, collaboration, and excellence in our mission to protect public health.

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