Are you ready to work for one of Washington's Top Workplaces? At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.
We are seeking a Validation Engineer I/II to join our Validation team. The position is responsible for working as a member of a cross functional team, providing hands-on support for applicable validation projects. The qualified individual should have the following:
- Experience with working in a CGMP environment, adhering to established SOPs, Batch Records, or other established Work Instructions.
- Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control is required.
- Experience/understanding of ICH Q9, Quality Risk Management.
Responsibilities include but are not limited to:
- Writing and executing qualification protocols as necessary.
- Participation in the change control process to determine impact of changes to facility, utilities, equipment, as applicable, and system owners.
- Investigation of exceptional conditions during the execution of protocols as well as other atypical events, deviations, and non-conformances as required.
- Abiding by CAPA system by contributing to/supporting CAPAs as needed.
- Other duties as assigned by supervisor.
- BS in technical discipline (Engineering preferred, Chemistry, Microbiology, Biology) or relevant work experience.
- Zero to 3 years applicable experience in Equipment/Utility Qualification.
- Demonstrated understanding of and experience working in a regulated environment specifically under cGMPs.
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field.
Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.