Engineer IV, Enterprise Computer Systems, Quality Assurance (QA)

Employer
Novavax
Location
Gaithersburg, MD
Posted
Jul 01, 2022
Closes
Jul 08, 2022
Ref
584662439
Industry
Engineering
Hours
Full Time
If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide. Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-MA$ cents A cents € zA' cents adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases. Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is searching for an Engineer IV, Enterprise Computer Systems, Quality Assurance (QA) to support Novavax' 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. The Engineer IV will develop QA procedures related to CSV review and approval, including writing detailed procedures (SOPs), as necessary, as well as, collaborate with relevant stakeholders to ensure all aspects of various enterprise computer solutions are included in Novavax' CSV Program. Responsibilities include but are not limited to: Support Novavax' 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' CSV Program. Participate in cross-functional meetings to support the implementation and maintenance of enterprise computer systems. Provide guidance in the evaluation of change controls to determine impact of proposed computer system changes on compliance. Provide guidance 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. Minimum Requirements: BS degree in a technical discipline (Computer Sciences preferred, Engineering, Chemistry, Microbiology, or Biology). Six to Eight 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 cGMP (current Good Manufacturing Practices), relevant ISO guidelines, and 21 CFR Part 11. Experience and Inspection interaction with FDA, EMA or other regulatory agencies preferred. Demonstrated 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 offers a base salary, annual bonus, equity grants, 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 is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law. Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption. #LI-AT Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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