Lead Process Validation Engineer

Novavax Gaithersburg , MD 20877

Posted 1 month ago

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc.(Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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.

We are seeking a Lead Process Validation Engineer to join our Manufacturing and Sciences Department in Gaithersburg, MD. Qualified individuals will play a leading role on for performing a wide range of process validation activities under general supervision as per applicable company procedures and regulatory guidance. Responsibilities may include, but are not limited to, leading and supporting PPQs, resin and membrane lifetime studies, CPV, mixing studies, media fills, and other projects. We are looking for candidates with either cell culture (upstream) or protein purification (downstream) experience. The candidate will collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. This role will be critical in ensuring establishment of robust processes across multiple locations meeting critical deliverables.

Responsibilities include but are not limited to:

  • Manage and support multi-site diagnostic activity to identify gaps in validation processes, practices, systems, and talent. Drive actions and provide expertise to develop solutions across the network that address gaps.

  • Work closely with Validation, Quality, Engineering, Technical Operations, and other functions to define and implement standards, guidelines, and best practices for Validation. This includes Process Validation, Cleaning Validation, Commissioning and Qualification (C&Q), and others.

  • Drive improvement/standardization in key Validation areas including Strategy, Quality Risk Management (QRM), Master Planning / Revalidation, Analysis/Testing approaches, and others.

  • Partner with the Continued Process Verification (CPV) Business Process Owner (BPO) and other leaders to ensure a streamlined, well aligned approach across the 3 Stages of Life-Cycle Validation.

  • Manage initiatives to develop and implement operating systems, process flows, and management tools for effectiveness throughout the Validation function.

  • Work with Corporate Quality, Technical staff, and Audits to develop and manage sustainability assessments and compliance audits to ensure effective Validation and to drive improvement.

  • Partner with OE and other functions to drive continuous improvement

  • Demonstrate highly effective oral and written communication skills and strong leadership ability. Be able to engage leadership and teams at different levels in the organization.

Minimum Requirements:

  • BS in Biochemistry, Microbiology, Biology, or closely related field, and more than 10 years relevant industrial experience. MS preferred.

  • Biologic/Vaccine manufacturing experience is required. Multi-year industrial purification experience with approved vaccines/biologics is preferred; direct experience with virus-derived recombinant products and/or viral particles is a plus.

  • Capable of performing multiple functions in a fast-paced environment. Strong technical protocol/report writing and good organization skills are required.

  • Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products.

  • Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.

  • Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements.

  • Demonstrated verbal and written skills in communicating scientific and technical information.

  • Proficient in Window based software including Excel, PowerPoint and Word.

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in 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 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.

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VIEW JOBS 12/24/2020 12:00:00 AM 2021-03-24T00:00 If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. 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. We are seeking a Senior Process Validation Engineer to join our Manufacturing and Sciences Department in Gaithersburg, MD. Qualified individuals will play a leading role on for performing a wide range of process validation activities under general supervision as per applicable company procedures and regulatory guidance. Responsibilities may include, but are not limited to, leading, and supporting PPQs, resin and membrane lifetime studies, CPV, mixing studies, media fills, and other projects. We are looking for candidates with either cell culture (upstream) or protein purification (downstream) experience. The candidate will collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. This role will be critical in ensuring establishment of robust processes across multiple locations meeting critical deliverables. Responsibilities include but are not limited to: * Provide validation and technical direction to lead project teams as needed * Develop/review and approve validation protocols and final reports and ensure compliance with cGMPs and current regulatory requirements. * Define and guide sampling plans for new product launch and technical transfer between sites. * Drive best practices toward continued or continuous process validation (CPV) * Train colleagues in validation best practices and health authority expectations * Responsible for generation, execution and reporting of process validation deliverables and supporting documentation. * Conduct risk assessments and validation impact assessments. * Represent Process Validation in project teams for both client and internal products. * Present validation packages and programs at regulatory inspections and client audits. * Manage small to medium cross-functional projects to ensure deliverables are completed on time and to a high level of quality. Minimum Requirements: * BS in Biochemistry, Microbiology, Biology, or closely related field, and more than 8 years relevant industrial experience. MS preferred. * Biologic/Vaccine manufacturing experience is required. Multi-year industrial purification experience with approved vaccines/biologics is preferred; direct experience with virus-derived recombinant products and/or viral particles is a plus. * Capable of performing multiple functions in a fast-paced environment. Strong technical protocol/report writing and good organization skills are required. * Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products. * Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation, and common analytical tools is preferred. * Excellent record keeping abilities to adequately record, analyze and document data generated in support of regulatory requirements. * Demonstrated verbal and written skills in communicating scientific and technical information. * Proficient in Window based software including Excel, PowerPoint and Word. Novavax is headquartered in Gaithersburg, Maryland with additional facilities in 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 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. Novavax Gaithersburg MD

Lead Process Validation Engineer

Novavax