Process Engineer - Growth-Minded Organization

Vaxxas seeks committed experts in Process Engineering to advance and enhance medical devices for the effective delivery of vaccines.

Overview of position

The Process Engineer is responsible for the development, implementation, validation and maintenance of processes for the manufacture of medical devices and combination pharmaceutical products. Duties will be across the product development lifecycle as well as ongoing production engineering support, including process improvement, and managing changes.

Key responsibilities

• Develop and deliver validated and reliable manufacturing processes for clinical trial and full-scale manufacturing according to business requirements.
• Undertake process design and detailed engineering including process mapping, process simulations, design calculations, process optimisation, sizing and selection of equipment.
• Contribute to process/product design and development. Constructively review designs to ensure quality, efficiency, and optimal cost for production.
• Prepare engineering deliverables (drawings and documents) such as process flow diagrams, equipment specifications, characterisation plans/protocols and process control philosophies.
• Perform characterisation, verification and validation activities including test method validation, PFMEAs, Gage R&R, risk assessments, facility / equipment / process validation (IQ, OQ, PQ) for combination medical devices within a manufacturing environment.

Required capabilities

• Bachelor’s degree in Engineering (Mechatronics / Electrical / Mechanical or similar) or equivalent degree with 2-5 years industry work experience.
• Knowledge of ISO standards and regulatory requirements for medical devices and pharmaceutical products, machine automation, process control, control systems and image processing.
• Experience in aseptic manufacturing and/or aseptic process validation is considered highly desirable.
• Ability to work within a multi-disciplinary team to generate solutions to complex problems.
• A high level of drive, enthusiasm and a ‘can do’ approach, comfortable working in a fast-paced, rapidly changing environment; a willingness to learn and to seek answers to problems and issues and propose solutions.
• Proven project management skills.

Selection criteria

• Demonstrated knowledge of process engineering, including knowledge of relevant regulations and standards and lean manufacturing principals.
• Process development and validation experience in the Medical Device and/or Pharmaceutical Industry.
• Skilled at completing commissioning, qualification, verification and validation of equipment and processes.
• Experience working with an ISO certified change management process and high-volume manufacturing.
• Knowledge of design and development of automated manufacturing equipment, introducing automated manufacturing equipment into production and working, together with fault finding of automated manufacturing equipment.
• Experience with creating documentation (WINs/SOPs), risk analysis and validation activities.

About Vaxxas

Vaxxas is a privately held, clinical stage biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious disease and oncology.

The company’s innovative, needle-free technology can eliminate or significantly reduce the need for vaccine refrigeration during storage and transportation, easing the resource and logistics burden of maintaining the vaccine cold chain.

In addition to a Phase I clinical study of a COVID-19 vaccine candidate, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic vaccination solutions, among multiple other clinical and pre-clinical programs.

The company has forged collaborations with leading global organisations in vaccine commercialisation, including Merck/MSD, CEPI, the World Health Organization (WHO), and the Bill and Melinda Gates Foundation.

Learn more at www.vaxxas.com

If you are prepared to leverage your skills as a Process Engineer to create an impact, we want to hear from you!

To be considered, please submit your Resume, together with a cover letter (outlining your core capabilities for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) by selecting the 'apply for this job' function. You will be contacted directly if your application is successful.