Senior Project Engineer

Novavax Gaithersburg , MD 20877

Posted 2 months 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 Senior Project Engineer to work in our Gaithersburg, MD Engineering group. This position reports directly to the Manager of Engineering, but works closely with all members of the Engineering and Tech Services Department, Validation, Facilities, and the Manufacturing Operations group.

Responsibilities include but are not limited to:

  • Lead and manage multiple projects simultaneously. Projects are broad ranging in discipline and vary from small focused tasks to large capital projects. Projects support Manufacturing, Lab Functions, and Facilities. Project objectives are also broad ranging and may focus on capital improvements, process and/or equipment improvement, cost containment, efficiency, and regulatory and/or compliance initiatives.

  • Facilitate and lead facilities engineering projects relating to new or upgraded equipment, processes, facilities, site operational initiatives, site compliance and quality initiatives, analyzing and remediating equipment and utility issues.

  • Act as technical point of contact for the stakeholder, customer, and management. Lead implementation of projects involving critical building systems including, but not limited to HVAC, ISO Classified Clean Rooms, WFI, Clean Steam, Clean Compressed Air and Gases, Chilled Water etc.

  • Communicate cross-functionally and with customers, vendors, suppliers, contractors, and management on project related activities. Collaborate with and coordinate in-house Engineering and Maintenance staff, outside vendors, and internal operations teams to effectively transition projects through their lifecycle, including design, implementation, start-up/commissioning, validation, and turn-over to the customer.

  • Prepare and manage project plans, schedules, and budgets to meet milestones and strategies. Deliver projects within timelines and budgets. Communicate project status and highlight critical path activities in a timely manner.

  • Manage and coordinate outside contractors, including engineering firms and consultants, construction firms and contractors, validation contractors, equipment manufacturers and/or vendors, regulatory officials and consultants, etc.

  • Ensure project requirements embrace and meet current GMP, EHS, and Financial standards and practices.

  • Conduct surveys and prepare schematic, preliminary and work drawings for the construction and maintenance of new or remodeled facilities.

  • Support project activities including assisting in the development of user requirement specifications, FAT, SAT, and commissioning/validation.

Minimum Requirements:

  • Engineering Degree with minimum of 10+ years of experience in the design and construction of GMP and non-GMP production facilities in a manufacturing plant environment, preferably in the Medical device or Pharmaceutical industries

  • Minimum 5 years' experience with life-science related projects and a cGMP manufacturing and development environment. Experience in biologics or vaccine manufacturing preferred. Good writing and communication skills.

  • Familiarization with execution of capital projects from design through commissioning and validation.

  • Experience working with and managing engineering firms, construction and trade contractors, validation contractors, and consultants.

  • Knowledge on personal computer and software like MS Word, Excel, Project and Power Point

  • Experience with CMMS and CMS systems

  • Able to work with minimal supervision

  • Must be available in emergency situations, and / or work flexible hours.

  • Experience developing and tracking schedules (Microsoft Project)

  • Experience with automation systems is highly desired. This includes building automation systems and process/equipment control systems.

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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Senior Project Engineer