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Senior Engineer - Process Validation

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Job Description - Senior Engineer - Process Validation

At AROA, our people come to work every day with passion and ideas that fuel our business and go home knowing they have made a real difference in the lives of others.


 


AROA, which is Maori for ‘understanding’, AROA is proudly New Zealand born and based. We develop, manufacture, and export innovative wound care products, improving the lives of millions around the world by unlocking extraordinary outcomes for our patients. Our mission is to be the global leader in regenerative healing, making our products and services accessible to everybody. 


 


We are seeking a Senior Engineer – Process Validation to ensure the quality and reliability of our medical device products from pilot processes to commercial scale-up and transfer. This position demands expertise in validation, strong project management skills, and the ability to collaborate effectively with internal stakeholders including engineering, manufacturing, quality and regulatory teams.  


 


Your key responsibilities: 


 



  • Plan, execute, and manage process development and validation studies



  • Collaborate with internal stakeholders, Engineering, and Quality teams to ensure smooth design transfer of new products into manufacturing



  • Generate technical protocols and reports



  • Support Design Controls in process risk assessment activities (e.g. pFMEA) where technical input is required



  • Identify opportunities for process optimisation and efficiency improvements



  • Perform root cause analysis to support manufacturing activities


What you’ll bring: 


 



  • Bachelor’s degree in biomedical or chemical engineering



  • Minimum of 5 years’ experience working in the medical device industry, (pharmaceutical or highly regulated field will be also considered) 



  • Experience with process validation and sterilization processes



  • Familiarity with statistical analysis software and tools (Minitab)



  • Strong project management skills and a collaborative mindset



  • Experience working in laboratory and workshop


 


Based in Airport Oaks with easy access to the motorway, there is plenty of free parking available around our offices. We also have an onsite gym, exercise classes and celebrations (including taking your birthday off). 


 


The successful candidate will be working with a diverse and inclusive team that works hard but celebrates and recognises its people. We have a great time doing stuff that’s never been done before! You'll also be working for a mission-led company dedicated to bringing regenerative healing to people around the world. We’re sure that’s something worth being a part of! 


 


To be considered for this opportunity you must have existing NZ working rights. 


 


Applications for this role will close 14 March 2025. 

Original job Senior Engineer - Process Validation posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
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