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Novavax, Inc.(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavaxis currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu™, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.Novavaxis a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Summary of the Position :
We are seeking a Project Manager to work in our Gaithersburg, MD Engineering group. This position reports to the Manager of Capital Projects 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 :
Minimum Requirements :
- The incumbent will be responsible for managing site based facility projects in a highly regulated cGMP environment, coordinate project scope definitions, manage project timelines and budgets, develop schedules and collaborate with stakeholders, etc.
- The incumbent will be responsible for working with vendors and consulting engineers to ensure project execution meets quality standards.
- Provides multi-disciplinary technical input to project design personnel to ensure compliance with site requirements/project specifications/codes and permitting requirements.
- Lead implementation of projects involving critical building systems including, but not limited to MEP, HVAC, ISO Classified Clean Rooms, WFI, Clean Steam, Clean Compressed Air and High Purity Gases, Cooling Tower Water, Chilled Water etc.
- Communicate cross-functionally with Project Stakeholders, 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.
- Define method and plans for project execution consistent with the business need and justification.
- Identify key project risk areas and potential resolution plan and related impact.
- Coordinate definition, preparation and delivery of project deliverables, design documents, and bid packages.
- Evaluates and approves engineering and project design changes, specifications, and drawing releases.
- Provide status and progress reports to management and project team.
- Coordinate plant training needs to ensure a smooth transition and project closing
- Conduct surveys and prepare schematic, preliminary and work drawings for the construction and maintenance of new or remodeled facilities.
- Consult with architects, engineers, owners, and contractors regarding preliminary layout, construction procedures, and code requirements that apply to building projects.
- Inspect existing facilities and utilities to determine their condition and prepares reports to document the condition, deficiencies observed, designs necessary for repairs, and estimated cost of repairs.
- Manages cost, schedule, and scope of facilities Capital projects including renovations, new equipment installs, and new construction.
- Oversees facility projects to ensure contractor compliance with safety, site cleanliness, and all current good manufacturing practices (cGMP’s).
- Coordinates projects with other departments to minimize risk and impact to existing and ongoing operations.
- Provide leadership and direction to staff involved in the designs of site facilities, and schedules
- Ability to maintain documents, records, and prepare reports and correspondence related to the work.
Manage and execute appropriate change control for the revision of existing equipment and systems maintenance SOPs.
- Develops and maintains a positive relationship with functional managers, lead personnel, and operators.
- Interacts with contractors and vendors to receive and negotiate bids and monitor the progress and completion of projects.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- Bachelor’s degree in Engineering with minimum of 5 years of experience in construction of GMP or 10+ years of equivalent work experience.
- Experience with capital projects in cGMP environment with demonstrated understanding of managing spending and schedule.
- Good writing and communication skills.
- Knowledge on personal computer and software like MS Word, Excel, Project and Power Point
- Experience with CMMS and QMS systems and reading/interpreting CAD drawings.
- Able to work with minimal supervision
- Must be available in emergency situations, and / or work flexible hours.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The 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)