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Manager, Site Engineer

Employer
Novavax
Location
Gaithersburg, Maryland, United States
Salary
Competitive
Start date
29 Apr 2022
Closing date
29 May 2022

View more

Discipline
Operations, Facilities Management
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

**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.**

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

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.

We are seeking a Manager, Site Engineering to work in our Gaithersburg, MD Engineering group. This position will be responsible for managing a team with an area of focus on supporting the design and operation of major facility systems and critical utilities, supporting operational space and utility process conditions. This position reports directly to the Senior Manager of Engineering but works closely with all members of the Engineering, Quality, IT, Validation, Facilities, Lab Operations, and the Manufacturing Operations groups to meet user requirements and optimal function of all Manufacturing, Laboratory and Building Space criteria.

Responsibilities include but are not limited to:
  • Manage a team of Site Engineers to meet expected deliverables and programs.
  • Facilitate and lead site 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.
  • Oversee the Drawing Management Program, including CAD Files for all building construction, Controlled Drawlings, GMP Drawings and Drawing Schematics.
  • Ensure that all appropriate Documentation and Drawing Specifications are generated in compliance with Novavax’s procedures and statutory requirements.
  • Act as a site engineering lead for project support. Including, Site Engineers, Manufacturing Operation Groups, Facilities and Lab Operations.
  • Act as the technical point of contact/subject matter expert for cGMP and non-GMP facilities equipment and systems. This includes HVAC, process gases, cooling and heating systems, electrical systems, etc.
  • Develop Standard Operating Procedures (SOPs) and Change Controls pertaining to setup, maintenance, and operation of equipment, facility, and utilities.
  • Leads cross-functional teams with contractors, customers, and vendors to successfully execute disruptive construction projects in labs/buildings. Planning, construction, and validation of state-of-the-art, multi-modular flex lab/contract development and manufacturing organization (CDMO). Experience Managing Air Systems, HVAC and Clean Dry Air (CDA) Generator.
  • Ensure project requirements embrace and meet current GMP, GLP, and EHS standards and practices.
  • Support Facilities and Engineering project activities including assisting in the development of user requirement specifications, FAT, SAT, and commissioning/validation.

Minimum Requirements:
  • Minimum of a Bachelor's degree in Engineering discipline (Chemical, Mechanical, Industrial or other relevant engineering discipline).
  • Minimum of 5 years’ experience in leading a team in biopharmaceutical site engineering.
  • Minimum of 5 years’ experience in maintenance of major facility systems and critical utilities in the pharmaceutical, biotechnology, or related industry.
  • Demonstrated leadership skills in directing engineering support to cGMP operations.
  • Direct experience supporting manufacturing facilities and utility systems within an FDA/EMA regulated environment.
  • Experience with automation systems is highly desired. This does not include the ability to execute computer/IT programming but the understanding of building automation systems and process/equipment control systems.
  • Experience with cGMP Quality Systems in a biotech/pharmaceutical environment. This includes experience with authorizing and executing equipment/system Change Controls, Deviations, and CAPAs.
  • Intermediate computer skills using MS Office suite and Office 365 cloud environment.
  • Experience with Auto CAD and Revit.
  • Exceptional attention to detail and follow-through.
  • Effective technical writing and presentation skills.

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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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)

Company

Find out more about working for our company

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Brief Company Description; 

We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world.

Our mission

We never rest in our quest to protect the health of people everywhere.

Novavax is here to make a difference. We’re a biotech company focused solely on developing life-saving vaccines to fight infectious diseases.

What sets us apart? Solid science tested by decades of research. Vaccines developed from trusted technology that are both safe and efficacious.

And a global network that will help ensure our vaccines reach everyone who needs them.

Company info
Website
Mini-site
Novavax
Location
21 Firstfield Rd
Gaithersburg
MD
20878
United States

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