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 Engineer, this position will be responsible to execute and manage project assignments in the evaluation, selection, and application of various engineering techniques, procedures, and criteria with minimal supervision. Independently plans, schedules, and leads detailed phases of the engineering work in a part of a major project or in a total project of moderate scope.
Responsibilities include but are not limited to:
- Responsible for process engineering and project management to support improvement of existing processes, and introduction of new products and processes. These projects are typically higher level capital projects with increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly.
- Responsible for Project management, process development, process improvement, IQ/OQ/PQ validations, and Manufacturing process troubleshooting. Must be able to manage the project in its entirety, and be able to perform / deliver specific project tasks as necessary.
- Responsible for analysis and upgrade of utility systems when needed (WFI, DIUF, HVAC, CCA, and steam generation). Knowledge in CO2 incubators, refrigerators and freezers, Clean Rooms both ISO and EU standards, BSC's, bioreactors, and autoclaves .
- Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture.
- Provide daily analytical and technical support to meet manufacturing objectives.
- Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.
- Lead teams in performing and updating Process FMECA risk management
- Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities
- Coordinate specific efforts of the project team, including the core team members (Manufacturing, Plant QA/QC/RA, Facilities, Materials Management, and Engineering) and supporting members (Corporate Regulatory, Finance, etc.). Includes such tasks as development of Manufacturing requirements, accounting documentation, specifications, validations, and Engineering drawings and ECN paperwork.
- Ensure that all appropriate documentation, drawings specifications are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO)
- Provide technical input for analysis of process changes
- Develop P&ID and PFD as required
- AutoCAD and/or SolidWorks experience preferred.
- BS in Engineering discipline (Chemical, Mechanical, Controls and/or Biotech,).
- Minimum of 5+ years' experience in maintenance of processing equipment and instrumentation in the pharmaceutical, biotechnology, or related industry.
- Strong facilities technical problem-solving abilities.
- Good understanding of PLC & automation Background in metrology an advantage.
- Experience in working within a quality management system.
- Experience of equipment validation, calibration and performing risk assessments.
- Knowledge of FDA regulatory requirements.
- Ability to document activities and keep organized records of maintenance and calibration activities.
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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