Novavax, Inc.(Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.Novavaxrecently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies.Novavaxis a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
Responsibilities include but are not limited to:
- Support Novavax's expanding enterprise computer applications, including the review of CSV User Requirements, Functional Specification and CSV protocols, as necessary.
- Provide CSV engineer's guidance on best practices for compliant, risk based methods and implementation of enterprise computer systems, including data migration.
- Develop QA procedures related to CSV review and approval, including writing detailed procedures (SOPs), as necessary.
- Collaborate with relevant stakeholders to ensure all aspects of various enterprise computer solutions are included in Novavax's CSV Program.
- Participate in cross-functional meetings to support the implementation and maintenance of enterprise computer systems.
- Assist in the evaluation of change controls to determine impact of proposed computer system changes on compliance.
- Assist in the investigation and review of CSV discrepancies found during the execution of protocols, as well as, other atypical events, deviations, and non-conformances, as required.
- BS degree in a technical discipline (Computer Sciences preferred, Engineering, Chemistry, Microbiology, or Biology).
- Three to four years of CSV experience, with a strong understanding of global enterprise electronic solutions.
- Experience with SAP, LV LIMS, Blue Mountain, laboratory analytical and PV Human Pharmacovigilance electronic systems a plus.
- Demonstrated understanding of and experience working in a regulated environment specifically cGMPs.
- Understanding of data integrity requirements and how to perform assessments.
- Experience and demonstrated skills working in highly collaborative environments.
- Project management experience a plus.
- Proven technical expertise in area(s) required.
- Travel to other sites may be required.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with Uppsala, Sweden and Bohumil,Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
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.
Equal Opportunity Employer/Veterans/Disabled
Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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